Erik Greb

WASHINGTON – Many patients with vitiligo are interested in treating their condition with vitamins, supplements, or a modified diet, but research on whether these measures have an impact remains limited, Nada Elbuluk, MD, said at the annual meeting of the American Academy of Dermatology.

While the literature suggests that supplements with antioxidant properties benefit patients who are receiving phototherapy for vitiligo, “we need more well designed, controlled studies in the future to know where this belongs in our treatment armamentarium,” said Dr. Elbuluk of the department of dermatology at the University of Southern California, Los Angeles.

During a session at the AAD meeting, Dr. Elbuluk, who is also director of the pigmentary disorders clinic at USC, reviewed the evidence for the use of these adjunctive therapies in patients with vitiligo.
 

Vitamins

The pathogenesis of vitiligo includes the overproduction of reactive oxygen species and oxidative stress, factors that contribute to melanocyte damage and death. In addition, many patients with vitiligo are deficient in certain vitamins and minerals, the basis of the hypothesis that supplementation could be beneficial, according to Dr. Elbuluk.

Vitamin B₁₂ and folic acid contribute to DNA repair, synthesis, and methylation, and researchers have hypothesized that these vitamins also play a role in melanin synthesis. In a review of the literature, Dr. Elbuluk and her colleagues found four studies that evaluated vitamin B₁₂ and folic acid in vitiligo. In one study, a controlled trial in which patients took B₁₂ and folic acid with and without phototherapy, the investigators observed no significant difference in repigmentation between groups. The other three studies were uncontrolled and thus provide an insufficient understanding of the effect of B₁₂ and folic acid, said Dr. Elbuluk.

Vitamin D is involved in melanocyte and keratinocyte growth and differentiation, and inhibits T cell activation. Data indicate that low vitamin D levels are common in patients with vitiligo and comorbid autoimmune diseases. In one study, patients who received narrow-band UVB had an increase in vitamin D levels that could contribute to photo-induced melanogenesis, and an open-label study indicated that patients who took vitamin D daily (without phototherapy) for 6 months had an increase of repigmentation over time. “Topical vitamin D analogs have also been used in vitiligo treatment with varying success,” Dr. Elbuluk noted.

“I check vitamin D levels on my patients and make sure that they are within normal range. But I think the degree of supplementation and its role in vitiligo needs to be further elucidated,” she said. And because vitamin D is fat soluble, there is a risk of toxicity if a patient takes too much.

Vitamin C, vitamin E, and alpha-lipoic acid have antioxidant properties. In a double-blind, randomized, controlled trial, one group of patients took vitamins C and E and alpha-lipoic acid for 2 months before and during treatment with narrow-band UVB twice per week (Clin Exp Dermatol. 2007 Nov;32[6]:631-6). Another group underwent phototherapy without supplementation. A significantly greater proportion of patients who received the antioxidants obtained more than 75% repigmentation compared with those who did not. In another study, 73% of patients who received oral vitamin E and narrow band UVB phototherapy had marked to excellent repigmentation, compared with 55.6% of those who had phototherapy only (J Clin Pharmacol. 2009 Jul;49[7]:852-5).

The results of these studies support the idea that antioxidants can stabilize disease, reduce oxidative stress, and improve the effect of phototherapy, Dr. Elbuluk said.
 

Herbal supplements

Several research teams have examined Ginkgo biloba as a possible treatment for vitiligo. This plant is native to China and has antioxidant and anti-inflammatory properties; its most common side effect is gastrointestinal distress. Because it entails a risk of coagulopathy, it may not be appropriate for patients receiving anticoagulant treatment, Dr. Elbuluk pointed out. In a double-blinded, randomized, controlled trial comparing ginkgo biloba alone with placebo in patients with vitiligo, treatment was associated with cessation of active disease in most patients, and more than 40% of patients receiving ginkgo biloba had 75% repigmentation or more.

Polypodium leucotomos, a fern native to Central and South America, protects against UV radiation damage, modulates the immune system, and has anti-inflammatory and antioxidant effects. It has a good safety profile and is well tolerated at a dose of 240 mg/day, she said. It sometimes causes gastrointestinal discomfort or pruritus. Several randomized, controlled trials in patients with vitiligo showed that supplementation with polypodium leucotomos improves repigmentation, particularly in photo-exposed areas, she noted.

Khellin is an extract from the Mediterranean khella plant that is thought to stimulate melanocyte proliferation and melanogenesis. Several studies have examined khellin supplementation in combination with phototherapy. Khellin can be administered orally or topically and appears to be more beneficial than sunlight or phototherapy alone in stabilizing disease or inducing repigmentation. Oral khellin can cause many side effects, including nausea, transaminitis, and hypotension, so researchers have been more interested in using topical khellin as a liposomal vehicle to improve drug delivery, Dr. Elbuluk said.
 

Minerals

Some patients with vitiligo have deficiencies in zinc and copper. Zinc is an antioxidant that aids wound healing, protects against free radicals, supports melanogenesis, and possibly prevents melanocyte death, but can cause gastrointestinal irritation. Copper, too, is an antioxidant and coenzyme involved in melanogenesis. One study compared topical steroid treatment with and without oral zinc supplementation. Dual treatment was associated with greater repigmentation, but the difference was not statistically significant. No studies have examined copper supplementation, she said.

L-phenylalanine, diet, and green tea

Investigators have proposed that the amino acid L-phenylalanine, a precursor to tyrosine in the pathway of melanin synthesis, might interfere with antibody production against melanocytes. This supplement is administered orally by weight, typically in conjunction with phototherapy or sunlight. Various studies have observed positive outcomes of L-phenylalanine combined with phototherapy or sunlight. L-phenylalanine tends to be safe and has been administered to children with vitiligo.

Many patients with vitiligo “have already tried diets by the time they come to me,” said Dr. Elbuluk. No controlled studies have analyzed the role of diet in the prevention or treatment of vitiligo, but case reports describe gluten-free diets in this population, including one report of a patient with celiac disease whose vitiligo improved after adoption of such a diet. Another case report described a patient without celiac disease who had refractory acrofacial vitiligo, which improved after the adoption of a gluten-free diet. Evidence supports a gluten-free diet for patients with celiac disease, but does not support this challenging diet for people without celiac disease, she pointed out.

Green tea includes catechins, which have antioxidant and anti-inflammatory properties. Its main component is epigallocatechin gallate (EGCG), which is thought to modulate T cell mediated responses. In one animal study, administration of EGCG delayed the onset of vitiligo and decreased the area of depigmentation in a mouse model. Although these findings are promising, clinical trials are needed to determine whether EGCG is beneficial in humans with vitiligo, said Dr. Elbuluk.

The literature on diets and supplementation as treatments for vitiligo has several shortcomings, with studies that used heterogeneous methodologies, and many that used nonstandard outcome measures that have not been validated. Sample sizes often are small, and many trials are uncontrolled. “These limitations make it harder to make sense of the data and have take-home conclusions,” Dr. Elbuluk said.

She had no disclosures.

[email protected]

SOURCE: Elbuluk N. AAD 19, Session S002.

WASHINGTON – Many patients with vitiligo are interested in treating their condition with vitamins, supplements, or a modified diet, but research on whether these measures have an impact remains limited, Nada Elbuluk, MD, said at the annual meeting of the American Academy of Dermatology.

While the literature suggests that supplements with antioxidant properties benefit patients who are receiving phototherapy for vitiligo, “we need more well designed, controlled studies in the future to know where this belongs in our treatment armamentarium,” said Dr. Elbuluk of the department of dermatology at the University of Southern California, Los Angeles.

During a session at the AAD meeting, Dr. Elbuluk, who is also director of the pigmentary disorders clinic at USC, reviewed the evidence for the use of these adjunctive therapies in patients with vitiligo.
 

Vitamins

The pathogenesis of vitiligo includes the overproduction of reactive oxygen species and oxidative stress, factors that contribute to melanocyte damage and death. In addition, many patients with vitiligo are deficient in certain vitamins and minerals, the basis of the hypothesis that supplementation could be beneficial, according to Dr. Elbuluk.

Vitamin B₁₂ and folic acid contribute to DNA repair, synthesis, and methylation, and researchers have hypothesized that these vitamins also play a role in melanin synthesis. In a review of the literature, Dr. Elbuluk and her colleagues found four studies that evaluated vitamin B₁₂ and folic acid in vitiligo. In one study, a controlled trial in which patients took B₁₂ and folic acid with and without phototherapy, the investigators observed no significant difference in repigmentation between groups. The other three studies were uncontrolled and thus provide an insufficient understanding of the effect of B₁₂ and folic acid, said Dr. Elbuluk.

Vitamin D is involved in melanocyte and keratinocyte growth and differentiation, and inhibits T cell activation. Data indicate that low vitamin D levels are common in patients with vitiligo and comorbid autoimmune diseases. In one study, patients who received narrow-band UVB had an increase in vitamin D levels that could contribute to photo-induced melanogenesis, and an open-label study indicated that patients who took vitamin D daily (without phototherapy) for 6 months had an increase of repigmentation over time. “Topical vitamin D analogs have also been used in vitiligo treatment with varying success,” Dr. Elbuluk noted.

“I check vitamin D levels on my patients and make sure that they are within normal range. But I think the degree of supplementation and its role in vitiligo needs to be further elucidated,” she said. And because vitamin D is fat soluble, there is a risk of toxicity if a patient takes too much.

Vitamin C, vitamin E, and alpha-lipoic acid have antioxidant properties. In a double-blind, randomized, controlled trial, one group of patients took vitamins C and E and alpha-lipoic acid for 2 months before and during treatment with narrow-band UVB twice per week (Clin Exp Dermatol. 2007 Nov;32[6]:631-6). Another group underwent phototherapy without supplementation. A significantly greater proportion of patients who received the antioxidants obtained more than 75% repigmentation compared with those who did not. In another study, 73% of patients who received oral vitamin E and narrow band UVB phototherapy had marked to excellent repigmentation, compared with 55.6% of those who had phototherapy only (J Clin Pharmacol. 2009 Jul;49[7]:852-5).

The results of these studies support the idea that antioxidants can stabilize disease, reduce oxidative stress, and improve the effect of phototherapy, Dr. Elbuluk said.
 

Herbal supplements

Several research teams have examined Ginkgo biloba as a possible treatment for vitiligo. This plant is native to China and has antioxidant and anti-inflammatory properties; its most common side effect is gastrointestinal distress. Because it entails a risk of coagulopathy, it may not be appropriate for patients receiving anticoagulant treatment, Dr. Elbuluk pointed out. In a double-blinded, randomized, controlled trial comparing ginkgo biloba alone with placebo in patients with vitiligo, treatment was associated with cessation of active disease in most patients, and more than 40% of patients receiving ginkgo biloba had 75% repigmentation or more.

Polypodium leucotomos, a fern native to Central and South America, protects against UV radiation damage, modulates the immune system, and has anti-inflammatory and antioxidant effects. It has a good safety profile and is well tolerated at a dose of 240 mg/day, she said. It sometimes causes gastrointestinal discomfort or pruritus. Several randomized, controlled trials in patients with vitiligo showed that supplementation with polypodium leucotomos improves repigmentation, particularly in photo-exposed areas, she noted.

Khellin is an extract from the Mediterranean khella plant that is thought to stimulate melanocyte proliferation and melanogenesis. Several studies have examined khellin supplementation in combination with phototherapy. Khellin can be administered orally or topically and appears to be more beneficial than sunlight or phototherapy alone in stabilizing disease or inducing repigmentation. Oral khellin can cause many side effects, including nausea, transaminitis, and hypotension, so researchers have been more interested in using topical khellin as a liposomal vehicle to improve drug delivery, Dr. Elbuluk said.
 

Minerals

Some patients with vitiligo have deficiencies in zinc and copper. Zinc is an antioxidant that aids wound healing, protects against free radicals, supports melanogenesis, and possibly prevents melanocyte death, but can cause gastrointestinal irritation. Copper, too, is an antioxidant and coenzyme involved in melanogenesis. One study compared topical steroid treatment with and without oral zinc supplementation. Dual treatment was associated with greater repigmentation, but the difference was not statistically significant. No studies have examined copper supplementation, she said.

L-phenylalanine, diet, and green tea

Investigators have proposed that the amino acid L-phenylalanine, a precursor to tyrosine in the pathway of melanin synthesis, might interfere with antibody production against melanocytes. This supplement is administered orally by weight, typically in conjunction with phototherapy or sunlight. Various studies have observed positive outcomes of L-phenylalanine combined with phototherapy or sunlight. L-phenylalanine tends to be safe and has been administered to children with vitiligo.

Many patients with vitiligo “have already tried diets by the time they come to me,” said Dr. Elbuluk. No controlled studies have analyzed the role of diet in the prevention or treatment of vitiligo, but case reports describe gluten-free diets in this population, including one report of a patient with celiac disease whose vitiligo improved after adoption of such a diet. Another case report described a patient without celiac disease who had refractory acrofacial vitiligo, which improved after the adoption of a gluten-free diet. Evidence supports a gluten-free diet for patients with celiac disease, but does not support this challenging diet for people without celiac disease, she pointed out.

Green tea includes catechins, which have antioxidant and anti-inflammatory properties. Its main component is epigallocatechin gallate (EGCG), which is thought to modulate T cell mediated responses. In one animal study, administration of EGCG delayed the onset of vitiligo and decreased the area of depigmentation in a mouse model. Although these findings are promising, clinical trials are needed to determine whether EGCG is beneficial in humans with vitiligo, said Dr. Elbuluk.

The literature on diets and supplementation as treatments for vitiligo has several shortcomings, with studies that used heterogeneous methodologies, and many that used nonstandard outcome measures that have not been validated. Sample sizes often are small, and many trials are uncontrolled. “These limitations make it harder to make sense of the data and have take-home conclusions,” Dr. Elbuluk said.

She had no disclosures.

[email protected]

SOURCE: Elbuluk N. AAD 19, Session S002.

WASHINGTON – Many patients with vitiligo are interested in treating their condition with vitamins, supplements, or a modified diet, but research on whether these measures have an impact remains limited, Nada Elbuluk, MD, said at the annual meeting of the American Academy of Dermatology.

While the literature suggests that supplements with antioxidant properties benefit patients who are receiving phototherapy for vitiligo, “we need more well designed, controlled studies in the future to know where this belongs in our treatment armamentarium,” said Dr. Elbuluk of the department of dermatology at the University of Southern California, Los Angeles.

During a session at the AAD meeting, Dr. Elbuluk, who is also director of the pigmentary disorders clinic at USC, reviewed the evidence for the use of these adjunctive therapies in patients with vitiligo.
 

Vitamins

The pathogenesis of vitiligo includes the overproduction of reactive oxygen species and oxidative stress, factors that contribute to melanocyte damage and death. In addition, many patients with vitiligo are deficient in certain vitamins and minerals, the basis of the hypothesis that supplementation could be beneficial, according to Dr. Elbuluk.

Vitamin B₁₂ and folic acid contribute to DNA repair, synthesis, and methylation, and researchers have hypothesized that these vitamins also play a role in melanin synthesis. In a review of the literature, Dr. Elbuluk and her colleagues found four studies that evaluated vitamin B₁₂ and folic acid in vitiligo. In one study, a controlled trial in which patients took B₁₂ and folic acid with and without phototherapy, the investigators observed no significant difference in repigmentation between groups. The other three studies were uncontrolled and thus provide an insufficient understanding of the effect of B₁₂ and folic acid, said Dr. Elbuluk.

Vitamin D is involved in melanocyte and keratinocyte growth and differentiation, and inhibits T cell activation. Data indicate that low vitamin D levels are common in patients with vitiligo and comorbid autoimmune diseases. In one study, patients who received narrow-band UVB had an increase in vitamin D levels that could contribute to photo-induced melanogenesis, and an open-label study indicated that patients who took vitamin D daily (without phototherapy) for 6 months had an increase of repigmentation over time. “Topical vitamin D analogs have also been used in vitiligo treatment with varying success,” Dr. Elbuluk noted.

“I check vitamin D levels on my patients and make sure that they are within normal range. But I think the degree of supplementation and its role in vitiligo needs to be further elucidated,” she said. And because vitamin D is fat soluble, there is a risk of toxicity if a patient takes too much.

Vitamin C, vitamin E, and alpha-lipoic acid have antioxidant properties. In a double-blind, randomized, controlled trial, one group of patients took vitamins C and E and alpha-lipoic acid for 2 months before and during treatment with narrow-band UVB twice per week (Clin Exp Dermatol. 2007 Nov;32[6]:631-6). Another group underwent phototherapy without supplementation. A significantly greater proportion of patients who received the antioxidants obtained more than 75% repigmentation compared with those who did not. In another study, 73% of patients who received oral vitamin E and narrow band UVB phototherapy had marked to excellent repigmentation, compared with 55.6% of those who had phototherapy only (J Clin Pharmacol. 2009 Jul;49[7]:852-5).

The results of these studies support the idea that antioxidants can stabilize disease, reduce oxidative stress, and improve the effect of phototherapy, Dr. Elbuluk said.
 

Herbal supplements

Several research teams have examined Ginkgo biloba as a possible treatment for vitiligo. This plant is native to China and has antioxidant and anti-inflammatory properties; its most common side effect is gastrointestinal distress. Because it entails a risk of coagulopathy, it may not be appropriate for patients receiving anticoagulant treatment, Dr. Elbuluk pointed out. In a double-blinded, randomized, controlled trial comparing ginkgo biloba alone with placebo in patients with vitiligo, treatment was associated with cessation of active disease in most patients, and more than 40% of patients receiving ginkgo biloba had 75% repigmentation or more.

Polypodium leucotomos, a fern native to Central and South America, protects against UV radiation damage, modulates the immune system, and has anti-inflammatory and antioxidant effects. It has a good safety profile and is well tolerated at a dose of 240 mg/day, she said. It sometimes causes gastrointestinal discomfort or pruritus. Several randomized, controlled trials in patients with vitiligo showed that supplementation with polypodium leucotomos improves repigmentation, particularly in photo-exposed areas, she noted.

Khellin is an extract from the Mediterranean khella plant that is thought to stimulate melanocyte proliferation and melanogenesis. Several studies have examined khellin supplementation in combination with phototherapy. Khellin can be administered orally or topically and appears to be more beneficial than sunlight or phototherapy alone in stabilizing disease or inducing repigmentation. Oral khellin can cause many side effects, including nausea, transaminitis, and hypotension, so researchers have been more interested in using topical khellin as a liposomal vehicle to improve drug delivery, Dr. Elbuluk said.
 

Minerals

Some patients with vitiligo have deficiencies in zinc and copper. Zinc is an antioxidant that aids wound healing, protects against free radicals, supports melanogenesis, and possibly prevents melanocyte death, but can cause gastrointestinal irritation. Copper, too, is an antioxidant and coenzyme involved in melanogenesis. One study compared topical steroid treatment with and without oral zinc supplementation. Dual treatment was associated with greater repigmentation, but the difference was not statistically significant. No studies have examined copper supplementation, she said.

L-phenylalanine, diet, and green tea

Investigators have proposed that the amino acid L-phenylalanine, a precursor to tyrosine in the pathway of melanin synthesis, might interfere with antibody production against melanocytes. This supplement is administered orally by weight, typically in conjunction with phototherapy or sunlight. Various studies have observed positive outcomes of L-phenylalanine combined with phototherapy or sunlight. L-phenylalanine tends to be safe and has been administered to children with vitiligo.

Many patients with vitiligo “have already tried diets by the time they come to me,” said Dr. Elbuluk. No controlled studies have analyzed the role of diet in the prevention or treatment of vitiligo, but case reports describe gluten-free diets in this population, including one report of a patient with celiac disease whose vitiligo improved after adoption of such a diet. Another case report described a patient without celiac disease who had refractory acrofacial vitiligo, which improved after the adoption of a gluten-free diet. Evidence supports a gluten-free diet for patients with celiac disease, but does not support this challenging diet for people without celiac disease, she pointed out.

Green tea includes catechins, which have antioxidant and anti-inflammatory properties. Its main component is epigallocatechin gallate (EGCG), which is thought to modulate T cell mediated responses. In one animal study, administration of EGCG delayed the onset of vitiligo and decreased the area of depigmentation in a mouse model. Although these findings are promising, clinical trials are needed to determine whether EGCG is beneficial in humans with vitiligo, said Dr. Elbuluk.

The literature on diets and supplementation as treatments for vitiligo has several shortcomings, with studies that used heterogeneous methodologies, and many that used nonstandard outcome measures that have not been validated. Sample sizes often are small, and many trials are uncontrolled. “These limitations make it harder to make sense of the data and have take-home conclusions,” Dr. Elbuluk said.

She had no disclosures.

[email protected]

SOURCE: Elbuluk N. AAD 19, Session S002.

HONOLULU – Carotid endarterectomy and carotid artery stenting with embolic protection have comparable efficacy and safety for asymptomatic patients with severe carotid artery stenosis, according to a pooled analysis presented at the International Stroke Conference sponsored by the American Heart Association. The treatments have similar rates of procedural complications and 4-year ipsilateral stroke, said Jon S. Matsumura, MD, chairman of the division of vascular surgery at the University of Wisconsin in Madison.

Asymptomatic severe carotid stenosis is the most common indication for carotid operations in the United States. Data support carotid endarterectomy in selected asymptomatic patients. Carotid artery stenting with embolic protection is a newer treatment option. Two of the five most recent large, randomized trials – CREST and ACT I – compared carotid stenting with endarterectomy in asymptomatic patients. Dr. Matsumura and his colleagues conducted a pooled analysis of these two trials to help inform the choice of treatment.

The investigators analyzed data from the CREST and ACT I studies, which had many similarities. The researchers in these trials carefully selected the surgeons and the interventionalists who participated in them. Each trial used single carotid stent systems, and both trials used routine, distally placed embolic protection. The trials had independent neurologic assessment, routine cardiac enzyme screening, and central clinical and adjudication committees.

Dr. Matsumura and his colleagues decided to conduct a patient-level pooled analysis and defined the primary endpoint as a composite of death, stroke, and myocardial infarction in the periprocedural period and any ipsilateral stroke within 4 years of randomization. They included in their analysis all randomized, asymptomatic patients who were younger than 80 years.

[email protected]

SOURCE: Hanlon B et al. ISC 2019, Abstract LB13.

HONOLULU – Carotid endarterectomy and carotid artery stenting with embolic protection have comparable efficacy and safety for asymptomatic patients with severe carotid artery stenosis, according to a pooled analysis presented at the International Stroke Conference sponsored by the American Heart Association. The treatments have similar rates of procedural complications and 4-year ipsilateral stroke, said Jon S. Matsumura, MD, chairman of the division of vascular surgery at the University of Wisconsin in Madison.

Asymptomatic severe carotid stenosis is the most common indication for carotid operations in the United States. Data support carotid endarterectomy in selected asymptomatic patients. Carotid artery stenting with embolic protection is a newer treatment option. Two of the five most recent large, randomized trials – CREST and ACT I – compared carotid stenting with endarterectomy in asymptomatic patients. Dr. Matsumura and his colleagues conducted a pooled analysis of these two trials to help inform the choice of treatment.

The investigators analyzed data from the CREST and ACT I studies, which had many similarities. The researchers in these trials carefully selected the surgeons and the interventionalists who participated in them. Each trial used single carotid stent systems, and both trials used routine, distally placed embolic protection. The trials had independent neurologic assessment, routine cardiac enzyme screening, and central clinical and adjudication committees.

Dr. Matsumura and his colleagues decided to conduct a patient-level pooled analysis and defined the primary endpoint as a composite of death, stroke, and myocardial infarction in the periprocedural period and any ipsilateral stroke within 4 years of randomization. They included in their analysis all randomized, asymptomatic patients who were younger than 80 years.

[email protected]

SOURCE: Hanlon B et al. ISC 2019, Abstract LB13.

HONOLULU – Carotid endarterectomy and carotid artery stenting with embolic protection have comparable efficacy and safety for asymptomatic patients with severe carotid artery stenosis, according to a pooled analysis presented at the International Stroke Conference sponsored by the American Heart Association. The treatments have similar rates of procedural complications and 4-year ipsilateral stroke, said Jon S. Matsumura, MD, chairman of the division of vascular surgery at the University of Wisconsin in Madison.

Asymptomatic severe carotid stenosis is the most common indication for carotid operations in the United States. Data support carotid endarterectomy in selected asymptomatic patients. Carotid artery stenting with embolic protection is a newer treatment option. Two of the five most recent large, randomized trials – CREST and ACT I – compared carotid stenting with endarterectomy in asymptomatic patients. Dr. Matsumura and his colleagues conducted a pooled analysis of these two trials to help inform the choice of treatment.

The investigators analyzed data from the CREST and ACT I studies, which had many similarities. The researchers in these trials carefully selected the surgeons and the interventionalists who participated in them. Each trial used single carotid stent systems, and both trials used routine, distally placed embolic protection. The trials had independent neurologic assessment, routine cardiac enzyme screening, and central clinical and adjudication committees.

Dr. Matsumura and his colleagues decided to conduct a patient-level pooled analysis and defined the primary endpoint as a composite of death, stroke, and myocardial infarction in the periprocedural period and any ipsilateral stroke within 4 years of randomization. They included in their analysis all randomized, asymptomatic patients who were younger than 80 years.

[email protected]

SOURCE: Hanlon B et al. ISC 2019, Abstract LB13.

WASHINGTON – A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

[email protected]

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

WASHINGTON – A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

[email protected]

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

WASHINGTON – A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

[email protected]

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

HONOLULU – EG-1962, a sustained-release microparticle formulation of nimodipine, does not significantly improve outcomes of aneurysmal subarachnoid hemorrhage, compared with standard of care, according to a study presented at the International Stroke Conference sponsored by the American Heart Association. However, the treatment does reduce the rate of angiographic vasospasm significantly and does not raise significant safety concerns.

Approximately 70% of patients with subarachnoid hemorrhage develop vasospasm, which can in turn cause delayed cerebral ischemia. The only evidence-based treatment for ischemia of the brain resulting from vasospasm is nimodipine, which has been the standard of care for more than a decade.

EG-1962 was developed to deliver higher amounts of nimodipine to the CNS and spastic vessels than oral nimodipine. The formulation contains 50-mcm particles of nimodipine combined with a biodegradable polymer. Pharmacokinetic studies indicate that EG-1962 successfully delivers higher amounts of nimodipine to the CNS than the oral formulation does.

A multisite, phase 3 trial

Stephan A. Mayer, MD, William T. Gossett Endowed Chair of Neurology at the Henry Ford Health System in Detroit, presented the trial results. He and his colleagues conducted NEWTON2, a phase 3 trial to evaluate the safety and efficacy of a single 600-mg intraventricular dose of EG-1962 in patients with aneurysmal subarachnoid hemorrhage, compared with those of oral nimodipine. Eligible participants had a World Federation of Neurosurgeons Score (WFNS) of 2-4, Glasgow Coma Scale scores of 7-14, and an indication for placement of an external ventricular drain (such as hydrocephalus). All patients had their aneurysms clipped or coiled.

On the first day after the operation, the investigators randomized patients in equal groups to EG-1962 plus oral placebo or oral nimodipine plus placebo injection. Patients in the EG-1962 arm received a 600-mg injection of nimodipine into the ventricular system. The primary endpoint was the proportion of subjects with an extended Glasgow Outcome Scale (eGOS) score of 6-8 (that is, minimal or mild disability) at day 90. The main secondary endpoint was the proportion of subjects with a Montreal Cognitive Assessment (MOCA) score of 26 or greater (indicating no important cognitive disability) at day 90. Safety outcomes included cerebral infarction, hypotension, and ventriculitis.

Dr. Mayer and his colleagues conducted the study at 65 centers in 11 countries. They planned to enroll 374 patients and conduct an interim analysis after the first 210 participants had their 90-day follow-up. An independent data monitoring committee reviewed the safety data as it was collected. The investigators stopped the study for futility after the preplanned interim analysis was completed.

The challenge of identifying responders

The two study arms were well matched on age and gender. The proportion of patients with poor WFNS was 45% in the EG-1962 arm and 53% in the oral nimodipine arm.

The rate of any vasospasm (such as symptomatic or by imaging) was 56% in the intervention group and 70% in the oral nimodipine group, a statistically significant difference. Follow-up angiography showed vasospasm in 50% of the intervention group, compared with 63% of the oral nimodipine group, which was also statistically significant.

When the investigators examined the primary endpoint, they found that 46% of patients who received EG-1962 had a favorable outcome, compared with 43% of patients who received oral nimodipine, a nonsignificant difference. If the investigators had defined a favorable outcome as an eGOS score of 4 or greater, “there would have been a more favorable effect,” said Dr. Mayer. The investigators found no difference between groups in MOCA score at day 90.

Subgroup analyses produced “puzzling” results, said Dr. Mayer. For example, more patients with poor-grade WFNS had a favorable outcome at 3 months in the EG-1962 group than in the nimodipine group, but fewer patients with good-grade WFNS had a favorable outcome at 3 months in the EG-1962 group than in the nimodipine group. In addition, the treatment effect was more evident in the United States than abroad.

The safety analysis indicated a trend toward less rescue therapy – defined as hypertensive therapy or any interventional approach – in the EG-1962 group (27%), compared with the oral nimodipine group (35%). The rate of hypotension was slightly lower in the EG-1962 group. The rates of treatment-emergent serious adverse events and hydrocephalus were not significantly different between groups.

The results may encourage neurologists to treat “extremely sick patients with highly refractory vasospasms,” said Dr. Mayer. “We have a biologically active agent. The problem is, though, that it’s very hard ... to prove efficacy in trials, because we do not fully understand who the responders were going to be.”

Dr. Mayer reported receiving consulting fees from Edge Therapeutics, the company that developed EG-1962, in the past for activities unrelated to this study. Other investigators are employees of Edge Therapeutics.

[email protected]

SOURCE: Mayer SA et al. ISC 2019, Abstract LB15.

HONOLULU – EG-1962, a sustained-release microparticle formulation of nimodipine, does not significantly improve outcomes of aneurysmal subarachnoid hemorrhage, compared with standard of care, according to a study presented at the International Stroke Conference sponsored by the American Heart Association. However, the treatment does reduce the rate of angiographic vasospasm significantly and does not raise significant safety concerns.

Approximately 70% of patients with subarachnoid hemorrhage develop vasospasm, which can in turn cause delayed cerebral ischemia. The only evidence-based treatment for ischemia of the brain resulting from vasospasm is nimodipine, which has been the standard of care for more than a decade.

EG-1962 was developed to deliver higher amounts of nimodipine to the CNS and spastic vessels than oral nimodipine. The formulation contains 50-mcm particles of nimodipine combined with a biodegradable polymer. Pharmacokinetic studies indicate that EG-1962 successfully delivers higher amounts of nimodipine to the CNS than the oral formulation does.

A multisite, phase 3 trial

Stephan A. Mayer, MD, William T. Gossett Endowed Chair of Neurology at the Henry Ford Health System in Detroit, presented the trial results. He and his colleagues conducted NEWTON2, a phase 3 trial to evaluate the safety and efficacy of a single 600-mg intraventricular dose of EG-1962 in patients with aneurysmal subarachnoid hemorrhage, compared with those of oral nimodipine. Eligible participants had a World Federation of Neurosurgeons Score (WFNS) of 2-4, Glasgow Coma Scale scores of 7-14, and an indication for placement of an external ventricular drain (such as hydrocephalus). All patients had their aneurysms clipped or coiled.

On the first day after the operation, the investigators randomized patients in equal groups to EG-1962 plus oral placebo or oral nimodipine plus placebo injection. Patients in the EG-1962 arm received a 600-mg injection of nimodipine into the ventricular system. The primary endpoint was the proportion of subjects with an extended Glasgow Outcome Scale (eGOS) score of 6-8 (that is, minimal or mild disability) at day 90. The main secondary endpoint was the proportion of subjects with a Montreal Cognitive Assessment (MOCA) score of 26 or greater (indicating no important cognitive disability) at day 90. Safety outcomes included cerebral infarction, hypotension, and ventriculitis.

Dr. Mayer and his colleagues conducted the study at 65 centers in 11 countries. They planned to enroll 374 patients and conduct an interim analysis after the first 210 participants had their 90-day follow-up. An independent data monitoring committee reviewed the safety data as it was collected. The investigators stopped the study for futility after the preplanned interim analysis was completed.

The challenge of identifying responders

The two study arms were well matched on age and gender. The proportion of patients with poor WFNS was 45% in the EG-1962 arm and 53% in the oral nimodipine arm.

The rate of any vasospasm (such as symptomatic or by imaging) was 56% in the intervention group and 70% in the oral nimodipine group, a statistically significant difference. Follow-up angiography showed vasospasm in 50% of the intervention group, compared with 63% of the oral nimodipine group, which was also statistically significant.

When the investigators examined the primary endpoint, they found that 46% of patients who received EG-1962 had a favorable outcome, compared with 43% of patients who received oral nimodipine, a nonsignificant difference. If the investigators had defined a favorable outcome as an eGOS score of 4 or greater, “there would have been a more favorable effect,” said Dr. Mayer. The investigators found no difference between groups in MOCA score at day 90.

Subgroup analyses produced “puzzling” results, said Dr. Mayer. For example, more patients with poor-grade WFNS had a favorable outcome at 3 months in the EG-1962 group than in the nimodipine group, but fewer patients with good-grade WFNS had a favorable outcome at 3 months in the EG-1962 group than in the nimodipine group. In addition, the treatment effect was more evident in the United States than abroad.

The safety analysis indicated a trend toward less rescue therapy – defined as hypertensive therapy or any interventional approach – in the EG-1962 group (27%), compared with the oral nimodipine group (35%). The rate of hypotension was slightly lower in the EG-1962 group. The rates of treatment-emergent serious adverse events and hydrocephalus were not significantly different between groups.

The results may encourage neurologists to treat “extremely sick patients with highly refractory vasospasms,” said Dr. Mayer. “We have a biologically active agent. The problem is, though, that it’s very hard ... to prove efficacy in trials, because we do not fully understand who the responders were going to be.”

Dr. Mayer reported receiving consulting fees from Edge Therapeutics, the company that developed EG-1962, in the past for activities unrelated to this study. Other investigators are employees of Edge Therapeutics.

[email protected]

SOURCE: Mayer SA et al. ISC 2019, Abstract LB15.

HONOLULU – EG-1962, a sustained-release microparticle formulation of nimodipine, does not significantly improve outcomes of aneurysmal subarachnoid hemorrhage, compared with standard of care, according to a study presented at the International Stroke Conference sponsored by the American Heart Association. However, the treatment does reduce the rate of angiographic vasospasm significantly and does not raise significant safety concerns.

Approximately 70% of patients with subarachnoid hemorrhage develop vasospasm, which can in turn cause delayed cerebral ischemia. The only evidence-based treatment for ischemia of the brain resulting from vasospasm is nimodipine, which has been the standard of care for more than a decade.

EG-1962 was developed to deliver higher amounts of nimodipine to the CNS and spastic vessels than oral nimodipine. The formulation contains 50-mcm particles of nimodipine combined with a biodegradable polymer. Pharmacokinetic studies indicate that EG-1962 successfully delivers higher amounts of nimodipine to the CNS than the oral formulation does.

A multisite, phase 3 trial

Stephan A. Mayer, MD, William T. Gossett Endowed Chair of Neurology at the Henry Ford Health System in Detroit, presented the trial results. He and his colleagues conducted NEWTON2, a phase 3 trial to evaluate the safety and efficacy of a single 600-mg intraventricular dose of EG-1962 in patients with aneurysmal subarachnoid hemorrhage, compared with those of oral nimodipine. Eligible participants had a World Federation of Neurosurgeons Score (WFNS) of 2-4, Glasgow Coma Scale scores of 7-14, and an indication for placement of an external ventricular drain (such as hydrocephalus). All patients had their aneurysms clipped or coiled.

On the first day after the operation, the investigators randomized patients in equal groups to EG-1962 plus oral placebo or oral nimodipine plus placebo injection. Patients in the EG-1962 arm received a 600-mg injection of nimodipine into the ventricular system. The primary endpoint was the proportion of subjects with an extended Glasgow Outcome Scale (eGOS) score of 6-8 (that is, minimal or mild disability) at day 90. The main secondary endpoint was the proportion of subjects with a Montreal Cognitive Assessment (MOCA) score of 26 or greater (indicating no important cognitive disability) at day 90. Safety outcomes included cerebral infarction, hypotension, and ventriculitis.

Dr. Mayer and his colleagues conducted the study at 65 centers in 11 countries. They planned to enroll 374 patients and conduct an interim analysis after the first 210 participants had their 90-day follow-up. An independent data monitoring committee reviewed the safety data as it was collected. The investigators stopped the study for futility after the preplanned interim analysis was completed.

The challenge of identifying responders

The two study arms were well matched on age and gender. The proportion of patients with poor WFNS was 45% in the EG-1962 arm and 53% in the oral nimodipine arm.

The rate of any vasospasm (such as symptomatic or by imaging) was 56% in the intervention group and 70% in the oral nimodipine group, a statistically significant difference. Follow-up angiography showed vasospasm in 50% of the intervention group, compared with 63% of the oral nimodipine group, which was also statistically significant.

When the investigators examined the primary endpoint, they found that 46% of patients who received EG-1962 had a favorable outcome, compared with 43% of patients who received oral nimodipine, a nonsignificant difference. If the investigators had defined a favorable outcome as an eGOS score of 4 or greater, “there would have been a more favorable effect,” said Dr. Mayer. The investigators found no difference between groups in MOCA score at day 90.

Subgroup analyses produced “puzzling” results, said Dr. Mayer. For example, more patients with poor-grade WFNS had a favorable outcome at 3 months in the EG-1962 group than in the nimodipine group, but fewer patients with good-grade WFNS had a favorable outcome at 3 months in the EG-1962 group than in the nimodipine group. In addition, the treatment effect was more evident in the United States than abroad.

The safety analysis indicated a trend toward less rescue therapy – defined as hypertensive therapy or any interventional approach – in the EG-1962 group (27%), compared with the oral nimodipine group (35%). The rate of hypotension was slightly lower in the EG-1962 group. The rates of treatment-emergent serious adverse events and hydrocephalus were not significantly different between groups.

The results may encourage neurologists to treat “extremely sick patients with highly refractory vasospasms,” said Dr. Mayer. “We have a biologically active agent. The problem is, though, that it’s very hard ... to prove efficacy in trials, because we do not fully understand who the responders were going to be.”

Dr. Mayer reported receiving consulting fees from Edge Therapeutics, the company that developed EG-1962, in the past for activities unrelated to this study. Other investigators are employees of Edge Therapeutics.

[email protected]

SOURCE: Mayer SA et al. ISC 2019, Abstract LB15.

HONOLULU – Administering glyceryl trinitrate (GTN) early after onset of ischemic stroke or transient ischemic attack (TIA) does not improve outcomes, according to data presented at the International Stroke Conference sponsored by the American Heart Association. Results suggest that GTN causes adverse effects in patients with intracerebral hemorrhage (ICH), but this observation is not definitive, according to the researchers. Study results were published online ahead of print Feb. 6 in the Lancet.

Nitric oxide is a regulatory molecule that has vasoactive effects and promotes blood pressure reduction. Vascular levels of nitric oxide are low in stroke, which suggests that the molecule may be a target for stroke treatment. GTN, a nitric oxide donor, lowered blood pressure and improved functional outcome among patients with acute stroke in the phase 2 Rapid Intervention with GTN in Hypertensive Stroke Trial (RIGHT).

Philip Bath, MD, Stroke Association Professor of Stroke Medicine at the University of Nottingham (England), and colleagues conducted the RIGHT-2 study to evaluate the safety and efficacy of GTN when administered early after onset of suspected stroke. Paramedics randomized patients in equal groups to a GTN patch or a sham patch in the ambulance. Three more patches were administered in the hospital on the following days. Active and sham patches looked similar and had no writing on them, thus ensuring effective blinding upon administration. Investigators followed up patients by telephone at 90 days to assess the modified Rankin Scale score and markers of disability, mood, cognition, and quality of life.

Eligible participants were adults who had dialed emergency services, independently or with assistance, because of a possible stroke. They had a Face, Arm, Speech, Time (FAST) score of 2 or 3, were within 4 hours of onset, and had a systolic blood pressure greater than 120 mm Hg. Patients from nursing homes, those with hypoglycemia, those who were unconscious, and those with a witnessed seizure were excluded.

Dr. Bath and colleagues planned to enroll 850 patients from five ambulance services in 30 hospitals across the United Kingdom. Data were to be examined through an intention-to-treat analysis. During the trial, however, the investigators observed that the rate of stroke mimics was 26%, rather than the 12% that they had anticipated. To ensure the proper power for the study, the investigators increased the sample size to 1,149 patients. They also changed the planned data analysis from intention-to-treat to hierarchical analysis. Specifically, the researchers planned to perform the primary analysis in patients with stroke or TIA. If the results were positive, then they would perform a standard intention-to-treat analysis.

More than 99% of patients received the first patch. Approximately 57% of the population received the first two patches. One reason for this decrease in adherence was that many patients were discharged from the hospital with a TIA or a stroke mimic. Participants’ average age was 72. The median time from onset to randomization was 71 minutes, and the median time to treatment was 73 minutes. Participants’ mean systolic blood pressure was 162 mm Hg. Approximately 60% of the patients had a FAST score of 3. About 50% of participants had ischemic stroke, 13% had ICH, 10% had TIA, and 26% had stroke mimics.

At 1 hour after treatment initiation, systolic blood pressure decreased by 6.2 mm Hg and diastolic blood pressure decreased by 2.7 mm Hg among patients who received GTN, compared with controls. At one day, the differences were 5.2 mm Hg and 2.5 mm Hg, respectively, in treated patients, compared with controls. Blood pressure became similar between groups thereafter, “in part because of the tachyphylaxis that we know happens with GTN,” said Dr. Bath.

The researchers found no evidence of an effect of GTN on functional outcome at 90 days in participants with stroke or transient ischemic attack. The adjusted common odds ratio of poor outcome was 1.25 in the GTN group, compared with the control group (95 % confidence interval, 0.97-1.60; P = .083). “We were close to getting a negative trial,” said Dr. Bath.

Subgroup analyses revealed differences in outcome according to the time to randomization. GTN had a negative effect in patients treated within 1 hour of onset. Results were neutral, but tended to be negative, in patients treated between 1 and 2 hours of onset. Results were neutral, but tended to be positive, among patients treated at more than 2 hours after onset. There was no difference between groups in the rate of mortality.

One of the study’s limitations was its single-blind design. In addition, the trial was conducted in a single country, and the investigators changed the protocol after it was initiated. “We had a higher-than-expected [stroke] mimic rate, although I’m reassured by most experts that ... this is probably about right,” said Dr. Bath.

A potential reason for the neutral results is the negative effect that GTN had among patients with ICH, said Dr. Bath. “In that very early first hour, we are of course breaking a law that we learned in medical school, which is that the first part of hemostasis is spasm. We gave an antispasmodic: a vasodilator,” he added. “That is speculation.”

The trial was funded by the British Heart Foundation. Dr. Bath declared a modest ownership interest in Platelet Solutions and consultant or advisory board positions with Moleac, DiaMedica, Phagenesis, Nestle, and ReNeuron. The other investigators declared no conflicts of interest.

[email protected]

SOURCE: Bath PM et al. ISC 2019, Abstract LB2.

HONOLULU – Administering glyceryl trinitrate (GTN) early after onset of ischemic stroke or transient ischemic attack (TIA) does not improve outcomes, according to data presented at the International Stroke Conference sponsored by the American Heart Association. Results suggest that GTN causes adverse effects in patients with intracerebral hemorrhage (ICH), but this observation is not definitive, according to the researchers. Study results were published online ahead of print Feb. 6 in the Lancet.

Nitric oxide is a regulatory molecule that has vasoactive effects and promotes blood pressure reduction. Vascular levels of nitric oxide are low in stroke, which suggests that the molecule may be a target for stroke treatment. GTN, a nitric oxide donor, lowered blood pressure and improved functional outcome among patients with acute stroke in the phase 2 Rapid Intervention with GTN in Hypertensive Stroke Trial (RIGHT).

Philip Bath, MD, Stroke Association Professor of Stroke Medicine at the University of Nottingham (England), and colleagues conducted the RIGHT-2 study to evaluate the safety and efficacy of GTN when administered early after onset of suspected stroke. Paramedics randomized patients in equal groups to a GTN patch or a sham patch in the ambulance. Three more patches were administered in the hospital on the following days. Active and sham patches looked similar and had no writing on them, thus ensuring effective blinding upon administration. Investigators followed up patients by telephone at 90 days to assess the modified Rankin Scale score and markers of disability, mood, cognition, and quality of life.

Eligible participants were adults who had dialed emergency services, independently or with assistance, because of a possible stroke. They had a Face, Arm, Speech, Time (FAST) score of 2 or 3, were within 4 hours of onset, and had a systolic blood pressure greater than 120 mm Hg. Patients from nursing homes, those with hypoglycemia, those who were unconscious, and those with a witnessed seizure were excluded.

Dr. Bath and colleagues planned to enroll 850 patients from five ambulance services in 30 hospitals across the United Kingdom. Data were to be examined through an intention-to-treat analysis. During the trial, however, the investigators observed that the rate of stroke mimics was 26%, rather than the 12% that they had anticipated. To ensure the proper power for the study, the investigators increased the sample size to 1,149 patients. They also changed the planned data analysis from intention-to-treat to hierarchical analysis. Specifically, the researchers planned to perform the primary analysis in patients with stroke or TIA. If the results were positive, then they would perform a standard intention-to-treat analysis.

More than 99% of patients received the first patch. Approximately 57% of the population received the first two patches. One reason for this decrease in adherence was that many patients were discharged from the hospital with a TIA or a stroke mimic. Participants’ average age was 72. The median time from onset to randomization was 71 minutes, and the median time to treatment was 73 minutes. Participants’ mean systolic blood pressure was 162 mm Hg. Approximately 60% of the patients had a FAST score of 3. About 50% of participants had ischemic stroke, 13% had ICH, 10% had TIA, and 26% had stroke mimics.

At 1 hour after treatment initiation, systolic blood pressure decreased by 6.2 mm Hg and diastolic blood pressure decreased by 2.7 mm Hg among patients who received GTN, compared with controls. At one day, the differences were 5.2 mm Hg and 2.5 mm Hg, respectively, in treated patients, compared with controls. Blood pressure became similar between groups thereafter, “in part because of the tachyphylaxis that we know happens with GTN,” said Dr. Bath.

The researchers found no evidence of an effect of GTN on functional outcome at 90 days in participants with stroke or transient ischemic attack. The adjusted common odds ratio of poor outcome was 1.25 in the GTN group, compared with the control group (95 % confidence interval, 0.97-1.60; P = .083). “We were close to getting a negative trial,” said Dr. Bath.

Subgroup analyses revealed differences in outcome according to the time to randomization. GTN had a negative effect in patients treated within 1 hour of onset. Results were neutral, but tended to be negative, in patients treated between 1 and 2 hours of onset. Results were neutral, but tended to be positive, among patients treated at more than 2 hours after onset. There was no difference between groups in the rate of mortality.

One of the study’s limitations was its single-blind design. In addition, the trial was conducted in a single country, and the investigators changed the protocol after it was initiated. “We had a higher-than-expected [stroke] mimic rate, although I’m reassured by most experts that ... this is probably about right,” said Dr. Bath.

A potential reason for the neutral results is the negative effect that GTN had among patients with ICH, said Dr. Bath. “In that very early first hour, we are of course breaking a law that we learned in medical school, which is that the first part of hemostasis is spasm. We gave an antispasmodic: a vasodilator,” he added. “That is speculation.”

The trial was funded by the British Heart Foundation. Dr. Bath declared a modest ownership interest in Platelet Solutions and consultant or advisory board positions with Moleac, DiaMedica, Phagenesis, Nestle, and ReNeuron. The other investigators declared no conflicts of interest.

[email protected]

SOURCE: Bath PM et al. ISC 2019, Abstract LB2.

HONOLULU – Administering glyceryl trinitrate (GTN) early after onset of ischemic stroke or transient ischemic attack (TIA) does not improve outcomes, according to data presented at the International Stroke Conference sponsored by the American Heart Association. Results suggest that GTN causes adverse effects in patients with intracerebral hemorrhage (ICH), but this observation is not definitive, according to the researchers. Study results were published online ahead of print Feb. 6 in the Lancet.

Nitric oxide is a regulatory molecule that has vasoactive effects and promotes blood pressure reduction. Vascular levels of nitric oxide are low in stroke, which suggests that the molecule may be a target for stroke treatment. GTN, a nitric oxide donor, lowered blood pressure and improved functional outcome among patients with acute stroke in the phase 2 Rapid Intervention with GTN in Hypertensive Stroke Trial (RIGHT).

Philip Bath, MD, Stroke Association Professor of Stroke Medicine at the University of Nottingham (England), and colleagues conducted the RIGHT-2 study to evaluate the safety and efficacy of GTN when administered early after onset of suspected stroke. Paramedics randomized patients in equal groups to a GTN patch or a sham patch in the ambulance. Three more patches were administered in the hospital on the following days. Active and sham patches looked similar and had no writing on them, thus ensuring effective blinding upon administration. Investigators followed up patients by telephone at 90 days to assess the modified Rankin Scale score and markers of disability, mood, cognition, and quality of life.

Eligible participants were adults who had dialed emergency services, independently or with assistance, because of a possible stroke. They had a Face, Arm, Speech, Time (FAST) score of 2 or 3, were within 4 hours of onset, and had a systolic blood pressure greater than 120 mm Hg. Patients from nursing homes, those with hypoglycemia, those who were unconscious, and those with a witnessed seizure were excluded.

Dr. Bath and colleagues planned to enroll 850 patients from five ambulance services in 30 hospitals across the United Kingdom. Data were to be examined through an intention-to-treat analysis. During the trial, however, the investigators observed that the rate of stroke mimics was 26%, rather than the 12% that they had anticipated. To ensure the proper power for the study, the investigators increased the sample size to 1,149 patients. They also changed the planned data analysis from intention-to-treat to hierarchical analysis. Specifically, the researchers planned to perform the primary analysis in patients with stroke or TIA. If the results were positive, then they would perform a standard intention-to-treat analysis.

More than 99% of patients received the first patch. Approximately 57% of the population received the first two patches. One reason for this decrease in adherence was that many patients were discharged from the hospital with a TIA or a stroke mimic. Participants’ average age was 72. The median time from onset to randomization was 71 minutes, and the median time to treatment was 73 minutes. Participants’ mean systolic blood pressure was 162 mm Hg. Approximately 60% of the patients had a FAST score of 3. About 50% of participants had ischemic stroke, 13% had ICH, 10% had TIA, and 26% had stroke mimics.

At 1 hour after treatment initiation, systolic blood pressure decreased by 6.2 mm Hg and diastolic blood pressure decreased by 2.7 mm Hg among patients who received GTN, compared with controls. At one day, the differences were 5.2 mm Hg and 2.5 mm Hg, respectively, in treated patients, compared with controls. Blood pressure became similar between groups thereafter, “in part because of the tachyphylaxis that we know happens with GTN,” said Dr. Bath.

The researchers found no evidence of an effect of GTN on functional outcome at 90 days in participants with stroke or transient ischemic attack. The adjusted common odds ratio of poor outcome was 1.25 in the GTN group, compared with the control group (95 % confidence interval, 0.97-1.60; P = .083). “We were close to getting a negative trial,” said Dr. Bath.

Subgroup analyses revealed differences in outcome according to the time to randomization. GTN had a negative effect in patients treated within 1 hour of onset. Results were neutral, but tended to be negative, in patients treated between 1 and 2 hours of onset. Results were neutral, but tended to be positive, among patients treated at more than 2 hours after onset. There was no difference between groups in the rate of mortality.

One of the study’s limitations was its single-blind design. In addition, the trial was conducted in a single country, and the investigators changed the protocol after it was initiated. “We had a higher-than-expected [stroke] mimic rate, although I’m reassured by most experts that ... this is probably about right,” said Dr. Bath.

A potential reason for the neutral results is the negative effect that GTN had among patients with ICH, said Dr. Bath. “In that very early first hour, we are of course breaking a law that we learned in medical school, which is that the first part of hemostasis is spasm. We gave an antispasmodic: a vasodilator,” he added. “That is speculation.”

The trial was funded by the British Heart Foundation. Dr. Bath declared a modest ownership interest in Platelet Solutions and consultant or advisory board positions with Moleac, DiaMedica, Phagenesis, Nestle, and ReNeuron. The other investigators declared no conflicts of interest.

[email protected]

SOURCE: Bath PM et al. ISC 2019, Abstract LB2.

WASHINGTON – In addition to improving patient access, teledermatology can increase the efficiency of dermatology services, according to a retrospective study presented at the annual meeting of the American Academy of Dermatology

Investigators previously have found that teledermatology systems, used by dermatologists to triage and manage patients, do improve patient access. Analyses of the clinical efficiency of these systems have demonstrated mixed results, however, and few such studies have been conducted in large, closed health care settings such as VA and county hospitals.

To investigate these open questions, Adam Zakaria, a third-year medical student at the University of California, San Francisco, and colleagues created a direct efficiency measure to analyze the teledermatology system at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), which was established in January 2015. ZSFG is a public safety net hospital that serves approximately 150,000 patients annually, according to Mr. Zakaria.

Before the teledermatology system was implemented, each patient seeking to consult a ZSFG dermatologist needed a referral from a primary care provider. Appointments were given on a first-come, first-served basis, “with little consideration for the acuity or the severity of the patient’s complaint,” Mr. Zakaria said at the meeting. Since the teledermatology system has been put in place, referring providers have submitted brief clinical histories and relevant photographs to the system. Once per week, a UCSF dermatology provider and three to four UCSF dermatology residents meet to review cases and decide whether patients can be treated by their primary care providers with recommendations from teledermatology, or whether they need to be seen in person at the dermatology clinic for further evaluation.

The investigators compared data for two patient cohorts: Patients scheduled for in-person clinic visits between June 2014 and December 2014 (the preteledermatology sample), and the second cohort, patients who were triaged through the teledermatology system between June 2017 and December 2017 and who only received a clinic appointment if they could not be managed by their referring provider with teledermatology recommendations (the postteledermatology sample). Data came from chart review, administrative record review, and records from the specialty care and diagnostics department at ZSFG.

Patient wait times for the live clinic and total patient cases handled per month were chosen as measures of accessibility. The measures of efficiency were the number of cases handled per dermatologist hour and the percentage of referrals managed without a live visit. Mr. Zakaria and colleagues performed two-tailed t-tests for each measure.

The analysis included 11,586 patients. Approximately 50% of the sample identified as nonwhite, approximately one-third of patients had a native language other than English, and more than three-quarters of patients had a form of public health insurance.

After the hospital implemented teledermatology, patient wait times decreased significantly (84.6 days vs. 6.7 days; P less than .001), total cases handled per month increased significantly (754 vs. 902; P = .008). In the postteledermatology period, 61.8% of teledermatology consults were handled without a live visit.

After the implementation of teledermatology, the number of cases handled per dermatologist hour increased from 2.27 to 2.63, which was statistically significant (P = .01). The total time that dermatologists spent reviewing teledermatology cases or seeing patients in the live dermatology clinic increased from 332 hours per month to 342 hours per month, an increase that was not statistically significant, however. When the researchers compared provider hours and resident hours, they again found no statistically significant difference.

The results indicate that “the benefits of teledermatology did carry over when applied in a large, closed health care setting,” said Mr. Zakaria. “Two future areas of investigation include evaluating the impact of teledermatology on the quality of resident education and assessing the costs and benefits that teledermatology imposes upon referring primary care providers.” Mr. Zakaria and his colleagues also are analyzing the costs of teledermatology.

[email protected]

SOURCE: Zakaria A et al. AAD 19, Abstract 10087.
 

WASHINGTON – In addition to improving patient access, teledermatology can increase the efficiency of dermatology services, according to a retrospective study presented at the annual meeting of the American Academy of Dermatology

Investigators previously have found that teledermatology systems, used by dermatologists to triage and manage patients, do improve patient access. Analyses of the clinical efficiency of these systems have demonstrated mixed results, however, and few such studies have been conducted in large, closed health care settings such as VA and county hospitals.

To investigate these open questions, Adam Zakaria, a third-year medical student at the University of California, San Francisco, and colleagues created a direct efficiency measure to analyze the teledermatology system at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), which was established in January 2015. ZSFG is a public safety net hospital that serves approximately 150,000 patients annually, according to Mr. Zakaria.

Before the teledermatology system was implemented, each patient seeking to consult a ZSFG dermatologist needed a referral from a primary care provider. Appointments were given on a first-come, first-served basis, “with little consideration for the acuity or the severity of the patient’s complaint,” Mr. Zakaria said at the meeting. Since the teledermatology system has been put in place, referring providers have submitted brief clinical histories and relevant photographs to the system. Once per week, a UCSF dermatology provider and three to four UCSF dermatology residents meet to review cases and decide whether patients can be treated by their primary care providers with recommendations from teledermatology, or whether they need to be seen in person at the dermatology clinic for further evaluation.

The investigators compared data for two patient cohorts: Patients scheduled for in-person clinic visits between June 2014 and December 2014 (the preteledermatology sample), and the second cohort, patients who were triaged through the teledermatology system between June 2017 and December 2017 and who only received a clinic appointment if they could not be managed by their referring provider with teledermatology recommendations (the postteledermatology sample). Data came from chart review, administrative record review, and records from the specialty care and diagnostics department at ZSFG.

Patient wait times for the live clinic and total patient cases handled per month were chosen as measures of accessibility. The measures of efficiency were the number of cases handled per dermatologist hour and the percentage of referrals managed without a live visit. Mr. Zakaria and colleagues performed two-tailed t-tests for each measure.

The analysis included 11,586 patients. Approximately 50% of the sample identified as nonwhite, approximately one-third of patients had a native language other than English, and more than three-quarters of patients had a form of public health insurance.

After the hospital implemented teledermatology, patient wait times decreased significantly (84.6 days vs. 6.7 days; P less than .001), total cases handled per month increased significantly (754 vs. 902; P = .008). In the postteledermatology period, 61.8% of teledermatology consults were handled without a live visit.

After the implementation of teledermatology, the number of cases handled per dermatologist hour increased from 2.27 to 2.63, which was statistically significant (P = .01). The total time that dermatologists spent reviewing teledermatology cases or seeing patients in the live dermatology clinic increased from 332 hours per month to 342 hours per month, an increase that was not statistically significant, however. When the researchers compared provider hours and resident hours, they again found no statistically significant difference.

The results indicate that “the benefits of teledermatology did carry over when applied in a large, closed health care setting,” said Mr. Zakaria. “Two future areas of investigation include evaluating the impact of teledermatology on the quality of resident education and assessing the costs and benefits that teledermatology imposes upon referring primary care providers.” Mr. Zakaria and his colleagues also are analyzing the costs of teledermatology.

[email protected]

SOURCE: Zakaria A et al. AAD 19, Abstract 10087.
 

WASHINGTON – In addition to improving patient access, teledermatology can increase the efficiency of dermatology services, according to a retrospective study presented at the annual meeting of the American Academy of Dermatology

Investigators previously have found that teledermatology systems, used by dermatologists to triage and manage patients, do improve patient access. Analyses of the clinical efficiency of these systems have demonstrated mixed results, however, and few such studies have been conducted in large, closed health care settings such as VA and county hospitals.

To investigate these open questions, Adam Zakaria, a third-year medical student at the University of California, San Francisco, and colleagues created a direct efficiency measure to analyze the teledermatology system at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), which was established in January 2015. ZSFG is a public safety net hospital that serves approximately 150,000 patients annually, according to Mr. Zakaria.

Before the teledermatology system was implemented, each patient seeking to consult a ZSFG dermatologist needed a referral from a primary care provider. Appointments were given on a first-come, first-served basis, “with little consideration for the acuity or the severity of the patient’s complaint,” Mr. Zakaria said at the meeting. Since the teledermatology system has been put in place, referring providers have submitted brief clinical histories and relevant photographs to the system. Once per week, a UCSF dermatology provider and three to four UCSF dermatology residents meet to review cases and decide whether patients can be treated by their primary care providers with recommendations from teledermatology, or whether they need to be seen in person at the dermatology clinic for further evaluation.

The investigators compared data for two patient cohorts: Patients scheduled for in-person clinic visits between June 2014 and December 2014 (the preteledermatology sample), and the second cohort, patients who were triaged through the teledermatology system between June 2017 and December 2017 and who only received a clinic appointment if they could not be managed by their referring provider with teledermatology recommendations (the postteledermatology sample). Data came from chart review, administrative record review, and records from the specialty care and diagnostics department at ZSFG.

Patient wait times for the live clinic and total patient cases handled per month were chosen as measures of accessibility. The measures of efficiency were the number of cases handled per dermatologist hour and the percentage of referrals managed without a live visit. Mr. Zakaria and colleagues performed two-tailed t-tests for each measure.

The analysis included 11,586 patients. Approximately 50% of the sample identified as nonwhite, approximately one-third of patients had a native language other than English, and more than three-quarters of patients had a form of public health insurance.

After the hospital implemented teledermatology, patient wait times decreased significantly (84.6 days vs. 6.7 days; P less than .001), total cases handled per month increased significantly (754 vs. 902; P = .008). In the postteledermatology period, 61.8% of teledermatology consults were handled without a live visit.

After the implementation of teledermatology, the number of cases handled per dermatologist hour increased from 2.27 to 2.63, which was statistically significant (P = .01). The total time that dermatologists spent reviewing teledermatology cases or seeing patients in the live dermatology clinic increased from 332 hours per month to 342 hours per month, an increase that was not statistically significant, however. When the researchers compared provider hours and resident hours, they again found no statistically significant difference.

The results indicate that “the benefits of teledermatology did carry over when applied in a large, closed health care setting,” said Mr. Zakaria. “Two future areas of investigation include evaluating the impact of teledermatology on the quality of resident education and assessing the costs and benefits that teledermatology imposes upon referring primary care providers.” Mr. Zakaria and his colleagues also are analyzing the costs of teledermatology.

[email protected]

SOURCE: Zakaria A et al. AAD 19, Abstract 10087.
 

WASHINGTON – Treating pruritus in children necessitates different approaches than those typically used to treat adult pruritus, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.

Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity  (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.

Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.

The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.

Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.

Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.

Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).

In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).

Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.

In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.

Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”

Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.

[email protected]

WASHINGTON – Treating pruritus in children necessitates different approaches than those typically used to treat adult pruritus, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.

Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity  (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.

Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.

The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.

Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.

Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.

Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).

In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).

Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.

In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.

Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”

Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.

[email protected]

WASHINGTON – Treating pruritus in children necessitates different approaches than those typically used to treat adult pruritus, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.

Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity  (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.

Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.

The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.

Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.

Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.

Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).

In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).

Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.

In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.

Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”

Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.

[email protected]

WASHINGTON – Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

[email protected]

WASHINGTON – Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

[email protected]

WASHINGTON – Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

[email protected]

WASHINGTON – When repigmentation therapy fails, dermatologists may offer depigmentation therapy to patients with vitiligo, Seemal Desai, MD, said at the annual meeting of the American Academy of Dermatology.

Depigmentation therapy is “an underutilized resource for those patients who have recalcitrant disease or whose disease is so bad that you have not been able to improve their clinical, visible outcome,” said Dr. Desai, clinical assistant professor of dermatology at the University of Texas, Dallas. “Some of these patients simply desire to be one uniform color.”

Therapy is administered through medications that destroy residual melanocytes with the goal of achieving a uniform appearance of the skin. Monobenzyl ether of hydroquinone (MBEH) is the most common drug used in depigmentation therapy, according to Dr. Desai. It is available in concentrations of 20% and 40% and can be compounded in other concentrations. At first, patients should apply MBEH to a nickel-sized area of the skin (such as the forearm, the back of the hand, or the thigh) for 3 or 4 days. Treatment is administered in the morning and evening, but not at bedtime. A common side effect is irritant contact dermatitis.

When the patient is able to tolerate the medication in the first area, he or she can apply it to larger areas of the skin. Parts of the body are treated one at a time, and successful treatment takes time, he noted. Hair may become depigmented, but patients can be assured that the eyes will not.

Repigmentation has been reported after sun exposure. For all patients undergoing depigmentation therapy, dermatologists should provide extensive counseling about the need for lifelong photoprotection, said Dr. Desai. Protective measures can include wide-brimmed hats and broad-spectrum sunscreen. Paradoxical repigmentation can be treated with a stronger concentration of MBEH, liquid nitrogen therapy, microdermabrasion, and peels.

For patients with vitiligo, which results from the immune-mediated destruction of melanocytes, dermatologists should assess the patient’s psychological status and discuss “the impact that the disease has on not only the patient, but also the family,” Dr. Desai said. “The psychological trauma from this disease, especially for our patients who have rapidly progressing vitiligo or who have failed multiple therapies, is something that we cannot discount.”

Patients with vitiligo often have comorbid depression, and evening of the skin tone that depigmentation provides can benefit the patient’s mental state, he observed. Patients with severe depression related to vitiligo should be referred to a psychologist or psychiatrist. Finally, counseling and appropriate patient selection for depigmentation is of paramount importance.

During the presentation, he noted that hair dyes, resin products and adhesives, detergents, and leather preservatives have been associated with vitiligo. Dermatologic drugs such as imiquimod, chemotherapeutic agents, and interferon also may cause the condition.

He referred to the thousands of reported cases of vitiligo related to rhododenol, a phenolic compound that has been used in cosmetics and topical products. Most cases resolved when those affected stopped using the product, but some developed vitiligo vulgaris. Cosmetics containing rhododenol have been recalled in Japan since 2013, but over-the-counter products in Asia and Africa have been found to contain similar compounds, so dermatologists should ask patients about their travel history and about what products they are using for their skin, Dr. Desai advised.

He reported receiving grants and research funding from AbbVie, Dermira, Dr. Reddy’s Laboratories, and Menlo Therapeutics and serving as a consultant for several pharmaceutical companies.

[email protected]

WASHINGTON – When repigmentation therapy fails, dermatologists may offer depigmentation therapy to patients with vitiligo, Seemal Desai, MD, said at the annual meeting of the American Academy of Dermatology.

Depigmentation therapy is “an underutilized resource for those patients who have recalcitrant disease or whose disease is so bad that you have not been able to improve their clinical, visible outcome,” said Dr. Desai, clinical assistant professor of dermatology at the University of Texas, Dallas. “Some of these patients simply desire to be one uniform color.”

Therapy is administered through medications that destroy residual melanocytes with the goal of achieving a uniform appearance of the skin. Monobenzyl ether of hydroquinone (MBEH) is the most common drug used in depigmentation therapy, according to Dr. Desai. It is available in concentrations of 20% and 40% and can be compounded in other concentrations. At first, patients should apply MBEH to a nickel-sized area of the skin (such as the forearm, the back of the hand, or the thigh) for 3 or 4 days. Treatment is administered in the morning and evening, but not at bedtime. A common side effect is irritant contact dermatitis.

When the patient is able to tolerate the medication in the first area, he or she can apply it to larger areas of the skin. Parts of the body are treated one at a time, and successful treatment takes time, he noted. Hair may become depigmented, but patients can be assured that the eyes will not.

Repigmentation has been reported after sun exposure. For all patients undergoing depigmentation therapy, dermatologists should provide extensive counseling about the need for lifelong photoprotection, said Dr. Desai. Protective measures can include wide-brimmed hats and broad-spectrum sunscreen. Paradoxical repigmentation can be treated with a stronger concentration of MBEH, liquid nitrogen therapy, microdermabrasion, and peels.

For patients with vitiligo, which results from the immune-mediated destruction of melanocytes, dermatologists should assess the patient’s psychological status and discuss “the impact that the disease has on not only the patient, but also the family,” Dr. Desai said. “The psychological trauma from this disease, especially for our patients who have rapidly progressing vitiligo or who have failed multiple therapies, is something that we cannot discount.”

Patients with vitiligo often have comorbid depression, and evening of the skin tone that depigmentation provides can benefit the patient’s mental state, he observed. Patients with severe depression related to vitiligo should be referred to a psychologist or psychiatrist. Finally, counseling and appropriate patient selection for depigmentation is of paramount importance.

During the presentation, he noted that hair dyes, resin products and adhesives, detergents, and leather preservatives have been associated with vitiligo. Dermatologic drugs such as imiquimod, chemotherapeutic agents, and interferon also may cause the condition.

He referred to the thousands of reported cases of vitiligo related to rhododenol, a phenolic compound that has been used in cosmetics and topical products. Most cases resolved when those affected stopped using the product, but some developed vitiligo vulgaris. Cosmetics containing rhododenol have been recalled in Japan since 2013, but over-the-counter products in Asia and Africa have been found to contain similar compounds, so dermatologists should ask patients about their travel history and about what products they are using for their skin, Dr. Desai advised.

He reported receiving grants and research funding from AbbVie, Dermira, Dr. Reddy’s Laboratories, and Menlo Therapeutics and serving as a consultant for several pharmaceutical companies.

[email protected]

WASHINGTON – When repigmentation therapy fails, dermatologists may offer depigmentation therapy to patients with vitiligo, Seemal Desai, MD, said at the annual meeting of the American Academy of Dermatology.

Depigmentation therapy is “an underutilized resource for those patients who have recalcitrant disease or whose disease is so bad that you have not been able to improve their clinical, visible outcome,” said Dr. Desai, clinical assistant professor of dermatology at the University of Texas, Dallas. “Some of these patients simply desire to be one uniform color.”

Therapy is administered through medications that destroy residual melanocytes with the goal of achieving a uniform appearance of the skin. Monobenzyl ether of hydroquinone (MBEH) is the most common drug used in depigmentation therapy, according to Dr. Desai. It is available in concentrations of 20% and 40% and can be compounded in other concentrations. At first, patients should apply MBEH to a nickel-sized area of the skin (such as the forearm, the back of the hand, or the thigh) for 3 or 4 days. Treatment is administered in the morning and evening, but not at bedtime. A common side effect is irritant contact dermatitis.

When the patient is able to tolerate the medication in the first area, he or she can apply it to larger areas of the skin. Parts of the body are treated one at a time, and successful treatment takes time, he noted. Hair may become depigmented, but patients can be assured that the eyes will not.

Repigmentation has been reported after sun exposure. For all patients undergoing depigmentation therapy, dermatologists should provide extensive counseling about the need for lifelong photoprotection, said Dr. Desai. Protective measures can include wide-brimmed hats and broad-spectrum sunscreen. Paradoxical repigmentation can be treated with a stronger concentration of MBEH, liquid nitrogen therapy, microdermabrasion, and peels.

For patients with vitiligo, which results from the immune-mediated destruction of melanocytes, dermatologists should assess the patient’s psychological status and discuss “the impact that the disease has on not only the patient, but also the family,” Dr. Desai said. “The psychological trauma from this disease, especially for our patients who have rapidly progressing vitiligo or who have failed multiple therapies, is something that we cannot discount.”

Patients with vitiligo often have comorbid depression, and evening of the skin tone that depigmentation provides can benefit the patient’s mental state, he observed. Patients with severe depression related to vitiligo should be referred to a psychologist or psychiatrist. Finally, counseling and appropriate patient selection for depigmentation is of paramount importance.

During the presentation, he noted that hair dyes, resin products and adhesives, detergents, and leather preservatives have been associated with vitiligo. Dermatologic drugs such as imiquimod, chemotherapeutic agents, and interferon also may cause the condition.

He referred to the thousands of reported cases of vitiligo related to rhododenol, a phenolic compound that has been used in cosmetics and topical products. Most cases resolved when those affected stopped using the product, but some developed vitiligo vulgaris. Cosmetics containing rhododenol have been recalled in Japan since 2013, but over-the-counter products in Asia and Africa have been found to contain similar compounds, so dermatologists should ask patients about their travel history and about what products they are using for their skin, Dr. Desai advised.

He reported receiving grants and research funding from AbbVie, Dermira, Dr. Reddy’s Laboratories, and Menlo Therapeutics and serving as a consultant for several pharmaceutical companies.

[email protected]

HONOLULU – Deferoxamine mesylate does not significantly improve 90-day outcomes after intracranial hemorrhage (ICH), according to trial results described at the International Stroke Conference sponsored by the American Heart Association. However, the drug is safe and well tolerated and data suggest that it may improve outcomes at 180 days.

Animal studies indicate that iron, which is released from hemolyzed red blood cells, accumulates in the brain after ICH and is associated with secondary neuronal injury and death. Researchers have found that deferoxamine, an iron chelator, provides neuroprotection and improves recovery after experimental ICH. The drug also has anti-inflammatory, antiapoptotic, and BP-lowering effects. Deferoxamine has been approved since the 1960s.

Magdy H. Selim, MD, PhD, a neurologist at Beth Israel Deaconess Medical Center in Boston, and colleagues hypothesized that treatment with deferoxamine could improve outcomes in patients with ICH. The researchers conducted a phase 2 clinical trial to evaluate whether deferoxamine should be studied in a phase 3 efficacy trial. In their multicenter, double-blind study, Dr. Selim and his colleagues randomized patients with spontaneous supratentorial ICH in equal groups to 32 mg/kg per day of deferoxamine or saline placebo. Treatments were administered as intravenous infusions for 3 consecutive days, and therapy was initiated within 24 hours after ICH onset. The follow-up period was 6 months.

Eligible participants had an National Institutes of Health Stroke Scale score of 6 or higher, a Glasgow Coma Scale score greater than 6, and had been functionally independent before the hemorrhage. The researchers excluded patients with a secondary cause for ICH or coagulopathy.

The primary endpoint in the futility analysis was the proportion of participants with a good clinical outcome – defined as a modified Rankin Scale (mRS) score of 0-2 – at 90 days and 180 days. The secondary endpoint was good outcome, defined as an mRS score of 0-3, at 90 days. Safety endpoints included all deferoxamine-related adverse events until day 7 or discharge (whichever was earlier) and serious adverse events through day 90.

Dr. Selim and his colleagues enrolled 294 participants in their trial, 3 of whom did not receive treatment. Of these included participants, 147 (50.5%) were randomized to placebo and 144 (49.5%) were randomized to deferoxamine. Participants’ mean age was 60.3 years, and 38.5% of the population was female.

Overall, the two study arms did not differ significantly according to demographic and clinical characteristics, however, there were more nonwhite patients in the deferoxamine arm than in the placebo arm, however. In addition, thalamic hemorrhage and intraventricular hemorrhage were more common in the placebo-treated group and hemorrhages in the putamen and basal ganglia were more common in the deferoxamine-treated group.

The rates of adverse events were comparable between the two study arms. Dr. Selim and his colleagues found no unexpected safety issues. Mortality was low, and the 90-day and 180-day mortality rates were comparable between the two treatment arms.

Approximately 34% of deferoxamine-treated patients and 33% of placebo-treated patients had an mRS score of 0-2 at 90 days. The adjusted absolute risk difference between arms was 0.6%; this result did not surpass the predefined futility threshold. The risk difference between groups for mRS score of 0-2 at 180 days was 8.6% in favor of deferoxamine, which did surpass the futility threshold.

The risk difference for meeting the secondary endpoint was 6.2% in favor of deferoxamine; this result did not surpass the futility threshold. Patients in both treatment groups improved between day 90 and day 180. The likelihood of good outcome was approximately 10% higher in the deferoxamine group at day 90 and 26% higher in the deferoxamine group at day 180.

“It is futile to conduct a phase 3 trial with the anticipation that treatment with deferoxamine would improve outcome, defined as mRS score of 0-2 at 90 days,” said Dr. Selim. “These data, together with the data from MISTIE and CLEAR, suggest that ICH trials need to have a longer follow-up period to capture the full extent of recovery after ICH. Several of our secondary analyses tended to favor deferoxamine over the placebo arm and leave open the possibility that deferoxamine might lead to improved outcome at 180 days.”

The researchers received support from the NIH and the National Institute of Neurological Disorders and Stroke.

[email protected]

SOURCE: Selim MH et al. ISC 2019, Abstract LB22.

HONOLULU – Deferoxamine mesylate does not significantly improve 90-day outcomes after intracranial hemorrhage (ICH), according to trial results described at the International Stroke Conference sponsored by the American Heart Association. However, the drug is safe and well tolerated and data suggest that it may improve outcomes at 180 days.

Animal studies indicate that iron, which is released from hemolyzed red blood cells, accumulates in the brain after ICH and is associated with secondary neuronal injury and death. Researchers have found that deferoxamine, an iron chelator, provides neuroprotection and improves recovery after experimental ICH. The drug also has anti-inflammatory, antiapoptotic, and BP-lowering effects. Deferoxamine has been approved since the 1960s.

Magdy H. Selim, MD, PhD, a neurologist at Beth Israel Deaconess Medical Center in Boston, and colleagues hypothesized that treatment with deferoxamine could improve outcomes in patients with ICH. The researchers conducted a phase 2 clinical trial to evaluate whether deferoxamine should be studied in a phase 3 efficacy trial. In their multicenter, double-blind study, Dr. Selim and his colleagues randomized patients with spontaneous supratentorial ICH in equal groups to 32 mg/kg per day of deferoxamine or saline placebo. Treatments were administered as intravenous infusions for 3 consecutive days, and therapy was initiated within 24 hours after ICH onset. The follow-up period was 6 months.

Eligible participants had an National Institutes of Health Stroke Scale score of 6 or higher, a Glasgow Coma Scale score greater than 6, and had been functionally independent before the hemorrhage. The researchers excluded patients with a secondary cause for ICH or coagulopathy.

The primary endpoint in the futility analysis was the proportion of participants with a good clinical outcome – defined as a modified Rankin Scale (mRS) score of 0-2 – at 90 days and 180 days. The secondary endpoint was good outcome, defined as an mRS score of 0-3, at 90 days. Safety endpoints included all deferoxamine-related adverse events until day 7 or discharge (whichever was earlier) and serious adverse events through day 90.

Dr. Selim and his colleagues enrolled 294 participants in their trial, 3 of whom did not receive treatment. Of these included participants, 147 (50.5%) were randomized to placebo and 144 (49.5%) were randomized to deferoxamine. Participants’ mean age was 60.3 years, and 38.5% of the population was female.

Overall, the two study arms did not differ significantly according to demographic and clinical characteristics, however, there were more nonwhite patients in the deferoxamine arm than in the placebo arm, however. In addition, thalamic hemorrhage and intraventricular hemorrhage were more common in the placebo-treated group and hemorrhages in the putamen and basal ganglia were more common in the deferoxamine-treated group.

The rates of adverse events were comparable between the two study arms. Dr. Selim and his colleagues found no unexpected safety issues. Mortality was low, and the 90-day and 180-day mortality rates were comparable between the two treatment arms.

Approximately 34% of deferoxamine-treated patients and 33% of placebo-treated patients had an mRS score of 0-2 at 90 days. The adjusted absolute risk difference between arms was 0.6%; this result did not surpass the predefined futility threshold. The risk difference between groups for mRS score of 0-2 at 180 days was 8.6% in favor of deferoxamine, which did surpass the futility threshold.

The risk difference for meeting the secondary endpoint was 6.2% in favor of deferoxamine; this result did not surpass the futility threshold. Patients in both treatment groups improved between day 90 and day 180. The likelihood of good outcome was approximately 10% higher in the deferoxamine group at day 90 and 26% higher in the deferoxamine group at day 180.

“It is futile to conduct a phase 3 trial with the anticipation that treatment with deferoxamine would improve outcome, defined as mRS score of 0-2 at 90 days,” said Dr. Selim. “These data, together with the data from MISTIE and CLEAR, suggest that ICH trials need to have a longer follow-up period to capture the full extent of recovery after ICH. Several of our secondary analyses tended to favor deferoxamine over the placebo arm and leave open the possibility that deferoxamine might lead to improved outcome at 180 days.”

The researchers received support from the NIH and the National Institute of Neurological Disorders and Stroke.

[email protected]

SOURCE: Selim MH et al. ISC 2019, Abstract LB22.

HONOLULU – Deferoxamine mesylate does not significantly improve 90-day outcomes after intracranial hemorrhage (ICH), according to trial results described at the International Stroke Conference sponsored by the American Heart Association. However, the drug is safe and well tolerated and data suggest that it may improve outcomes at 180 days.

Animal studies indicate that iron, which is released from hemolyzed red blood cells, accumulates in the brain after ICH and is associated with secondary neuronal injury and death. Researchers have found that deferoxamine, an iron chelator, provides neuroprotection and improves recovery after experimental ICH. The drug also has anti-inflammatory, antiapoptotic, and BP-lowering effects. Deferoxamine has been approved since the 1960s.

Magdy H. Selim, MD, PhD, a neurologist at Beth Israel Deaconess Medical Center in Boston, and colleagues hypothesized that treatment with deferoxamine could improve outcomes in patients with ICH. The researchers conducted a phase 2 clinical trial to evaluate whether deferoxamine should be studied in a phase 3 efficacy trial. In their multicenter, double-blind study, Dr. Selim and his colleagues randomized patients with spontaneous supratentorial ICH in equal groups to 32 mg/kg per day of deferoxamine or saline placebo. Treatments were administered as intravenous infusions for 3 consecutive days, and therapy was initiated within 24 hours after ICH onset. The follow-up period was 6 months.

Eligible participants had an National Institutes of Health Stroke Scale score of 6 or higher, a Glasgow Coma Scale score greater than 6, and had been functionally independent before the hemorrhage. The researchers excluded patients with a secondary cause for ICH or coagulopathy.

The primary endpoint in the futility analysis was the proportion of participants with a good clinical outcome – defined as a modified Rankin Scale (mRS) score of 0-2 – at 90 days and 180 days. The secondary endpoint was good outcome, defined as an mRS score of 0-3, at 90 days. Safety endpoints included all deferoxamine-related adverse events until day 7 or discharge (whichever was earlier) and serious adverse events through day 90.

Dr. Selim and his colleagues enrolled 294 participants in their trial, 3 of whom did not receive treatment. Of these included participants, 147 (50.5%) were randomized to placebo and 144 (49.5%) were randomized to deferoxamine. Participants’ mean age was 60.3 years, and 38.5% of the population was female.

Overall, the two study arms did not differ significantly according to demographic and clinical characteristics, however, there were more nonwhite patients in the deferoxamine arm than in the placebo arm, however. In addition, thalamic hemorrhage and intraventricular hemorrhage were more common in the placebo-treated group and hemorrhages in the putamen and basal ganglia were more common in the deferoxamine-treated group.

The rates of adverse events were comparable between the two study arms. Dr. Selim and his colleagues found no unexpected safety issues. Mortality was low, and the 90-day and 180-day mortality rates were comparable between the two treatment arms.

Approximately 34% of deferoxamine-treated patients and 33% of placebo-treated patients had an mRS score of 0-2 at 90 days. The adjusted absolute risk difference between arms was 0.6%; this result did not surpass the predefined futility threshold. The risk difference between groups for mRS score of 0-2 at 180 days was 8.6% in favor of deferoxamine, which did surpass the futility threshold.

The risk difference for meeting the secondary endpoint was 6.2% in favor of deferoxamine; this result did not surpass the futility threshold. Patients in both treatment groups improved between day 90 and day 180. The likelihood of good outcome was approximately 10% higher in the deferoxamine group at day 90 and 26% higher in the deferoxamine group at day 180.

“It is futile to conduct a phase 3 trial with the anticipation that treatment with deferoxamine would improve outcome, defined as mRS score of 0-2 at 90 days,” said Dr. Selim. “These data, together with the data from MISTIE and CLEAR, suggest that ICH trials need to have a longer follow-up period to capture the full extent of recovery after ICH. Several of our secondary analyses tended to favor deferoxamine over the placebo arm and leave open the possibility that deferoxamine might lead to improved outcome at 180 days.”

The researchers received support from the NIH and the National Institute of Neurological Disorders and Stroke.

[email protected]

SOURCE: Selim MH et al. ISC 2019, Abstract LB22.