Doug Brunk

LOS ANGELES – A significantly higher proportion of euthyroid patients with thyroid disease suffer from anxiety than from depression, regardless of Hashimoto’s autoimmunity, results from a cross-sectional study have shown.

“Thyroid disease is often associated with impaired quality of life and psychological well-being,” lead study author Anette Merke, MD, MS, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “In daily practice, anxiety and depression complaints are common in patients with thyroid dysfunctions. While depressive symptoms are often associated with hypothyroidism, anxiety is claimed to be mainly linked to hyperthyroidism. Data on euthyroid patients with thyroid disease are controversial. Some studies point out that autoimmunity itself contributes to psychosomatic malfunctions. Overall, the mechanisms underlying the interaction between thyroid dysfunction and neuropsychiatric processes are still unknown.”

Dr. Merke, of the Thyroid Center Bergstrasse in Bensheim, Germany, and her husband/coauthor Jüergen Merke, MD, PhD, used the self-administered German version of the validated Hospital Anxiety and Depression Scale (HADS-D) to perform a cross-sectional study of 215 euthyroid adults with thyroid disease between January and February of 2019. Of the 14 items on the measure, half relate to anxiety and the other half to depression. Each item on the HADS-D is scored from 0-3, and a score of 10 or higher is considered a positive case of anxiety or depression. Patients completed the HADS-D within 3 months of routine lab testing, and the researchers collected the patients’ demographic data after they had assessed the individual scores.

Of the 215 study participants, most (89%) were women, the mean age was 47 years, and the mean anxiety and depression scores were 6.68 and 4.68, respectively (P = .0001). There was no significant difference in severity with respect to anxiety or depression. Of the 70 patients (33%) with antibody-positive Hashimoto’s thyroiditis, the mean anxiety and depression scores were 7.26 and 4.17.


In patients with HADS-D scores of 10 or greater, 50 (23%) had prominent anxiety scores (mean, 12.4), whereas 22 (10%) had prominent depression scores (mean, 13.18). Among the subset of Hashimoto’s thyroiditis patients, 18 (26%) had a mean anxiety score of 12.6 and 8 (11%) had a mean depression score of 13.18. Overall, significantly more cases were found in those who met criteria for anxiety, compared with those who met criteria for depression (P = .0001), with no significant difference in severity of either condition.

Depressive symptoms are usually more closely associated with thyroid disease, and there are more studies that have examined that relationship, so “we were surprised to find no significant difference in depressive symptoms between our study cohort and the German general population,” Dr. Merke said. “We were also surprised that anxiety had a significantly higher incidence in the cohort.”

The findings suggest that clinicians should focus on signs of anxiety symptoms when dealing with euthyroid patients with thyroid disease who report psychosomatic impairments, she continued, especially when patients complain of not being able to relax and release somatic tension.

“According to HADS, fears and worries are an expression of anxiety, and not of depression,” Dr. Merke said. “With this in mind, doctors [should] actively ask [about] the above-mentioned symptoms and advise patients to learn relaxation techniques to improve their quality of life. Interdisciplinary collaboration is needed between clinicians and psychotherapeutic professionals for the sake of the patients and to evaluate a cause-and-effect relationship and potential risk factors for development of psychosomatic cofactors in thyroid and other chronic somatic diseases. We should all be aware that misinterpretation or even denial of psychosomatic complaints may lead to complications and even a higher mortality of somatic diseases, as shown for chronic heart failure. This could also be true for thyroid disease.”

Dr Merke acknowledged certain limitations of the study, including the fact that neither the duration of thyroid disease nor the use of specific thyroid medications was assessed. In addition, “the definition of euthyroidism in our study is somewhat broad, especially compared with the recommendations of the [American Association of Clinical Endocrinologists],” she said. “Division of the respective thyroid hormone status into quartiles may be helpful to indicate the critical thyroid hormone serum concentration, which may be associated with clinically relevant anxiety symptoms in euthyroid patients.”

Dr. Merke reported having no financial disclosures or conflict of interest.

[email protected]

LOS ANGELES – A significantly higher proportion of euthyroid patients with thyroid disease suffer from anxiety than from depression, regardless of Hashimoto’s autoimmunity, results from a cross-sectional study have shown.

“Thyroid disease is often associated with impaired quality of life and psychological well-being,” lead study author Anette Merke, MD, MS, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “In daily practice, anxiety and depression complaints are common in patients with thyroid dysfunctions. While depressive symptoms are often associated with hypothyroidism, anxiety is claimed to be mainly linked to hyperthyroidism. Data on euthyroid patients with thyroid disease are controversial. Some studies point out that autoimmunity itself contributes to psychosomatic malfunctions. Overall, the mechanisms underlying the interaction between thyroid dysfunction and neuropsychiatric processes are still unknown.”

Dr. Merke, of the Thyroid Center Bergstrasse in Bensheim, Germany, and her husband/coauthor Jüergen Merke, MD, PhD, used the self-administered German version of the validated Hospital Anxiety and Depression Scale (HADS-D) to perform a cross-sectional study of 215 euthyroid adults with thyroid disease between January and February of 2019. Of the 14 items on the measure, half relate to anxiety and the other half to depression. Each item on the HADS-D is scored from 0-3, and a score of 10 or higher is considered a positive case of anxiety or depression. Patients completed the HADS-D within 3 months of routine lab testing, and the researchers collected the patients’ demographic data after they had assessed the individual scores.

Of the 215 study participants, most (89%) were women, the mean age was 47 years, and the mean anxiety and depression scores were 6.68 and 4.68, respectively (P = .0001). There was no significant difference in severity with respect to anxiety or depression. Of the 70 patients (33%) with antibody-positive Hashimoto’s thyroiditis, the mean anxiety and depression scores were 7.26 and 4.17.


In patients with HADS-D scores of 10 or greater, 50 (23%) had prominent anxiety scores (mean, 12.4), whereas 22 (10%) had prominent depression scores (mean, 13.18). Among the subset of Hashimoto’s thyroiditis patients, 18 (26%) had a mean anxiety score of 12.6 and 8 (11%) had a mean depression score of 13.18. Overall, significantly more cases were found in those who met criteria for anxiety, compared with those who met criteria for depression (P = .0001), with no significant difference in severity of either condition.

Depressive symptoms are usually more closely associated with thyroid disease, and there are more studies that have examined that relationship, so “we were surprised to find no significant difference in depressive symptoms between our study cohort and the German general population,” Dr. Merke said. “We were also surprised that anxiety had a significantly higher incidence in the cohort.”

The findings suggest that clinicians should focus on signs of anxiety symptoms when dealing with euthyroid patients with thyroid disease who report psychosomatic impairments, she continued, especially when patients complain of not being able to relax and release somatic tension.

“According to HADS, fears and worries are an expression of anxiety, and not of depression,” Dr. Merke said. “With this in mind, doctors [should] actively ask [about] the above-mentioned symptoms and advise patients to learn relaxation techniques to improve their quality of life. Interdisciplinary collaboration is needed between clinicians and psychotherapeutic professionals for the sake of the patients and to evaluate a cause-and-effect relationship and potential risk factors for development of psychosomatic cofactors in thyroid and other chronic somatic diseases. We should all be aware that misinterpretation or even denial of psychosomatic complaints may lead to complications and even a higher mortality of somatic diseases, as shown for chronic heart failure. This could also be true for thyroid disease.”

Dr Merke acknowledged certain limitations of the study, including the fact that neither the duration of thyroid disease nor the use of specific thyroid medications was assessed. In addition, “the definition of euthyroidism in our study is somewhat broad, especially compared with the recommendations of the [American Association of Clinical Endocrinologists],” she said. “Division of the respective thyroid hormone status into quartiles may be helpful to indicate the critical thyroid hormone serum concentration, which may be associated with clinically relevant anxiety symptoms in euthyroid patients.”

Dr. Merke reported having no financial disclosures or conflict of interest.

[email protected]

LOS ANGELES – A significantly higher proportion of euthyroid patients with thyroid disease suffer from anxiety than from depression, regardless of Hashimoto’s autoimmunity, results from a cross-sectional study have shown.

“Thyroid disease is often associated with impaired quality of life and psychological well-being,” lead study author Anette Merke, MD, MS, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “In daily practice, anxiety and depression complaints are common in patients with thyroid dysfunctions. While depressive symptoms are often associated with hypothyroidism, anxiety is claimed to be mainly linked to hyperthyroidism. Data on euthyroid patients with thyroid disease are controversial. Some studies point out that autoimmunity itself contributes to psychosomatic malfunctions. Overall, the mechanisms underlying the interaction between thyroid dysfunction and neuropsychiatric processes are still unknown.”

Dr. Merke, of the Thyroid Center Bergstrasse in Bensheim, Germany, and her husband/coauthor Jüergen Merke, MD, PhD, used the self-administered German version of the validated Hospital Anxiety and Depression Scale (HADS-D) to perform a cross-sectional study of 215 euthyroid adults with thyroid disease between January and February of 2019. Of the 14 items on the measure, half relate to anxiety and the other half to depression. Each item on the HADS-D is scored from 0-3, and a score of 10 or higher is considered a positive case of anxiety or depression. Patients completed the HADS-D within 3 months of routine lab testing, and the researchers collected the patients’ demographic data after they had assessed the individual scores.

Of the 215 study participants, most (89%) were women, the mean age was 47 years, and the mean anxiety and depression scores were 6.68 and 4.68, respectively (P = .0001). There was no significant difference in severity with respect to anxiety or depression. Of the 70 patients (33%) with antibody-positive Hashimoto’s thyroiditis, the mean anxiety and depression scores were 7.26 and 4.17.


In patients with HADS-D scores of 10 or greater, 50 (23%) had prominent anxiety scores (mean, 12.4), whereas 22 (10%) had prominent depression scores (mean, 13.18). Among the subset of Hashimoto’s thyroiditis patients, 18 (26%) had a mean anxiety score of 12.6 and 8 (11%) had a mean depression score of 13.18. Overall, significantly more cases were found in those who met criteria for anxiety, compared with those who met criteria for depression (P = .0001), with no significant difference in severity of either condition.

Depressive symptoms are usually more closely associated with thyroid disease, and there are more studies that have examined that relationship, so “we were surprised to find no significant difference in depressive symptoms between our study cohort and the German general population,” Dr. Merke said. “We were also surprised that anxiety had a significantly higher incidence in the cohort.”

The findings suggest that clinicians should focus on signs of anxiety symptoms when dealing with euthyroid patients with thyroid disease who report psychosomatic impairments, she continued, especially when patients complain of not being able to relax and release somatic tension.

“According to HADS, fears and worries are an expression of anxiety, and not of depression,” Dr. Merke said. “With this in mind, doctors [should] actively ask [about] the above-mentioned symptoms and advise patients to learn relaxation techniques to improve their quality of life. Interdisciplinary collaboration is needed between clinicians and psychotherapeutic professionals for the sake of the patients and to evaluate a cause-and-effect relationship and potential risk factors for development of psychosomatic cofactors in thyroid and other chronic somatic diseases. We should all be aware that misinterpretation or even denial of psychosomatic complaints may lead to complications and even a higher mortality of somatic diseases, as shown for chronic heart failure. This could also be true for thyroid disease.”

Dr Merke acknowledged certain limitations of the study, including the fact that neither the duration of thyroid disease nor the use of specific thyroid medications was assessed. In addition, “the definition of euthyroidism in our study is somewhat broad, especially compared with the recommendations of the [American Association of Clinical Endocrinologists],” she said. “Division of the respective thyroid hormone status into quartiles may be helpful to indicate the critical thyroid hormone serum concentration, which may be associated with clinically relevant anxiety symptoms in euthyroid patients.”

Dr. Merke reported having no financial disclosures or conflict of interest.

[email protected]

LOS ANGELES – Patients with poor glycemic control, especially those with a hemoglobin A_1c (HbA_1c) level of more than 9%, face an increased risk for developing diabetic ketoacidosis (DKA), results from a registry study have demonstrated.

The findings come from an analysis of the 2016-2017 Type 1 Diabetes Exchange Clinic Registry dataset that researchers, led by Carol Wysham, MD, presented at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“This study is unique in that we have stratified patients based on A_1c, and identified factors and patient characteristics associated with a greater risk of DKA as glycemic control diminishes,” Dr. Wysham, an endocrinologist at MultiCare Rockwood Clinic Diabetes & Endocrinology Center in Spokane, Wash., said in advance of the meeting. “Multiple interrelated factors, such as lower levels of education and household income, relationship status, access to private health insurance, being younger, and smoking, all affect a patient’s ability to properly manage insulin dosing and are associated with a higher risk of DKA. Health care providers should continue to monitor and educate all patients on the risk factors associated with developing DKA, and be vigilant in patients with an A_1c of more than 9%.”

Dr. Wysham and her colleagues conducted a cross-sectional analysis of 6,242 patients in the registry. They examined associations between patient characteristics and treatment patterns with the occurrence of a DKA event in three categories of HbA_1c: 7% to less than 8%, 8% to less than 9%, and 9% or greater. The researchers used chi-square or Fisher exact tests to compare DKA and non-DKA groups for categorical variables and t tests to compare continuous variables.

Of the 6,242 patients, 43% had an HbA_1c from 7% to less than 8% (cohort 1), 31% had an HbA_1c of 8% to less than 9% (cohort 2), and 30% had an HbA_1c of 9% or greater (cohort 3). In all, 269 patients reported a DKA event. In addition, 1.7% of those in cohort 1 had a DKA episode versus 2.3% of those in cohort 2 and 9.5% of those in cohort 3.

In patients in cohort 1, the researchers observed no significant associations between individual patient demographic, socioeconomic, or treatment patterns and DKA incidence. In patients in cohort 2, race, marital status, insurance coverage, and annual household income were significantly associated with DKA incidence (P less than .01). In patients in cohort 3, DKA incidence was significantly associated with the same patterns as those in cohort 2, with the addition of age, type 1 diabetes duration, sex, education level, body mass index, and insulin delivery method (P less than .01).

On adjusted multivariate analysis, the researchers observed no significant associations between the factors studied and DKA in patients in cohort 2. In patients in cohort 3, only household income, smoking status, body mass index, and insulin delivery method (injection) were associated with DKA.

Dr. Wysham said she was surprised to learn that the patient characteristics and socioeconomic factors associated with DKA in patients with an HbA_1c of more than 9% start to become less significant risk factors as patients achieved better glycemic control.

“Also, in the past, insulin pump users tended to have higher rates of DKA, compared with patients taking multiple daily insulin injections,” she said. “That phenomenon no longer seems to apply, and in this dataset, patients with an HbA_1c of more than 9% and who were taking multiple daily injections had significantly higher risk of DKA than did pump users. Insulin delivery method was not a contributing factor to DKA risk at all in patients with an HbA_1c of less than 9%.”

Dr. Wysham acknowledged certain limitations of the analysis, including the fact that the registry data “are collected from patients treated at diabetes centers of excellence and may not reflect the population as a whole. Data could have been collected from medical records and/or self-reported questionnaires from patients. Self-reported data are subjective and are limited to the patient’s own recollections.”

Dr. Wysham disclosed that she has received honoraria for advising, consulting, and/or speaking from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Dexcom, Novo Nordisk, and Sanofi. She also disclosed having received research funding from Mylan and Novo Nordisk that went to her institution.

[email protected]

LOS ANGELES – Patients with poor glycemic control, especially those with a hemoglobin A_1c (HbA_1c) level of more than 9%, face an increased risk for developing diabetic ketoacidosis (DKA), results from a registry study have demonstrated.

The findings come from an analysis of the 2016-2017 Type 1 Diabetes Exchange Clinic Registry dataset that researchers, led by Carol Wysham, MD, presented at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“This study is unique in that we have stratified patients based on A_1c, and identified factors and patient characteristics associated with a greater risk of DKA as glycemic control diminishes,” Dr. Wysham, an endocrinologist at MultiCare Rockwood Clinic Diabetes & Endocrinology Center in Spokane, Wash., said in advance of the meeting. “Multiple interrelated factors, such as lower levels of education and household income, relationship status, access to private health insurance, being younger, and smoking, all affect a patient’s ability to properly manage insulin dosing and are associated with a higher risk of DKA. Health care providers should continue to monitor and educate all patients on the risk factors associated with developing DKA, and be vigilant in patients with an A_1c of more than 9%.”

Dr. Wysham and her colleagues conducted a cross-sectional analysis of 6,242 patients in the registry. They examined associations between patient characteristics and treatment patterns with the occurrence of a DKA event in three categories of HbA_1c: 7% to less than 8%, 8% to less than 9%, and 9% or greater. The researchers used chi-square or Fisher exact tests to compare DKA and non-DKA groups for categorical variables and t tests to compare continuous variables.

Of the 6,242 patients, 43% had an HbA_1c from 7% to less than 8% (cohort 1), 31% had an HbA_1c of 8% to less than 9% (cohort 2), and 30% had an HbA_1c of 9% or greater (cohort 3). In all, 269 patients reported a DKA event. In addition, 1.7% of those in cohort 1 had a DKA episode versus 2.3% of those in cohort 2 and 9.5% of those in cohort 3.

In patients in cohort 1, the researchers observed no significant associations between individual patient demographic, socioeconomic, or treatment patterns and DKA incidence. In patients in cohort 2, race, marital status, insurance coverage, and annual household income were significantly associated with DKA incidence (P less than .01). In patients in cohort 3, DKA incidence was significantly associated with the same patterns as those in cohort 2, with the addition of age, type 1 diabetes duration, sex, education level, body mass index, and insulin delivery method (P less than .01).

On adjusted multivariate analysis, the researchers observed no significant associations between the factors studied and DKA in patients in cohort 2. In patients in cohort 3, only household income, smoking status, body mass index, and insulin delivery method (injection) were associated with DKA.

Dr. Wysham said she was surprised to learn that the patient characteristics and socioeconomic factors associated with DKA in patients with an HbA_1c of more than 9% start to become less significant risk factors as patients achieved better glycemic control.

“Also, in the past, insulin pump users tended to have higher rates of DKA, compared with patients taking multiple daily insulin injections,” she said. “That phenomenon no longer seems to apply, and in this dataset, patients with an HbA_1c of more than 9% and who were taking multiple daily injections had significantly higher risk of DKA than did pump users. Insulin delivery method was not a contributing factor to DKA risk at all in patients with an HbA_1c of less than 9%.”

Dr. Wysham acknowledged certain limitations of the analysis, including the fact that the registry data “are collected from patients treated at diabetes centers of excellence and may not reflect the population as a whole. Data could have been collected from medical records and/or self-reported questionnaires from patients. Self-reported data are subjective and are limited to the patient’s own recollections.”

Dr. Wysham disclosed that she has received honoraria for advising, consulting, and/or speaking from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Dexcom, Novo Nordisk, and Sanofi. She also disclosed having received research funding from Mylan and Novo Nordisk that went to her institution.

[email protected]

LOS ANGELES – Patients with poor glycemic control, especially those with a hemoglobin A_1c (HbA_1c) level of more than 9%, face an increased risk for developing diabetic ketoacidosis (DKA), results from a registry study have demonstrated.

The findings come from an analysis of the 2016-2017 Type 1 Diabetes Exchange Clinic Registry dataset that researchers, led by Carol Wysham, MD, presented at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“This study is unique in that we have stratified patients based on A_1c, and identified factors and patient characteristics associated with a greater risk of DKA as glycemic control diminishes,” Dr. Wysham, an endocrinologist at MultiCare Rockwood Clinic Diabetes & Endocrinology Center in Spokane, Wash., said in advance of the meeting. “Multiple interrelated factors, such as lower levels of education and household income, relationship status, access to private health insurance, being younger, and smoking, all affect a patient’s ability to properly manage insulin dosing and are associated with a higher risk of DKA. Health care providers should continue to monitor and educate all patients on the risk factors associated with developing DKA, and be vigilant in patients with an A_1c of more than 9%.”

Dr. Wysham and her colleagues conducted a cross-sectional analysis of 6,242 patients in the registry. They examined associations between patient characteristics and treatment patterns with the occurrence of a DKA event in three categories of HbA_1c: 7% to less than 8%, 8% to less than 9%, and 9% or greater. The researchers used chi-square or Fisher exact tests to compare DKA and non-DKA groups for categorical variables and t tests to compare continuous variables.

Of the 6,242 patients, 43% had an HbA_1c from 7% to less than 8% (cohort 1), 31% had an HbA_1c of 8% to less than 9% (cohort 2), and 30% had an HbA_1c of 9% or greater (cohort 3). In all, 269 patients reported a DKA event. In addition, 1.7% of those in cohort 1 had a DKA episode versus 2.3% of those in cohort 2 and 9.5% of those in cohort 3.

In patients in cohort 1, the researchers observed no significant associations between individual patient demographic, socioeconomic, or treatment patterns and DKA incidence. In patients in cohort 2, race, marital status, insurance coverage, and annual household income were significantly associated with DKA incidence (P less than .01). In patients in cohort 3, DKA incidence was significantly associated with the same patterns as those in cohort 2, with the addition of age, type 1 diabetes duration, sex, education level, body mass index, and insulin delivery method (P less than .01).

On adjusted multivariate analysis, the researchers observed no significant associations between the factors studied and DKA in patients in cohort 2. In patients in cohort 3, only household income, smoking status, body mass index, and insulin delivery method (injection) were associated with DKA.

Dr. Wysham said she was surprised to learn that the patient characteristics and socioeconomic factors associated with DKA in patients with an HbA_1c of more than 9% start to become less significant risk factors as patients achieved better glycemic control.

“Also, in the past, insulin pump users tended to have higher rates of DKA, compared with patients taking multiple daily insulin injections,” she said. “That phenomenon no longer seems to apply, and in this dataset, patients with an HbA_1c of more than 9% and who were taking multiple daily injections had significantly higher risk of DKA than did pump users. Insulin delivery method was not a contributing factor to DKA risk at all in patients with an HbA_1c of less than 9%.”

Dr. Wysham acknowledged certain limitations of the analysis, including the fact that the registry data “are collected from patients treated at diabetes centers of excellence and may not reflect the population as a whole. Data could have been collected from medical records and/or self-reported questionnaires from patients. Self-reported data are subjective and are limited to the patient’s own recollections.”

Dr. Wysham disclosed that she has received honoraria for advising, consulting, and/or speaking from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Dexcom, Novo Nordisk, and Sanofi. She also disclosed having received research funding from Mylan and Novo Nordisk that went to her institution.

[email protected]

LOS ANGELES – Following 6 months of treatment with the investigational agent levoketoconazole, several clinical signs and symptoms of Cushing’s disease improved, including acne, hirsutism, and peripheral edema, as did patient-reported quality of life and symptoms of depression.

The findings come from an analysis of secondary endpoints among patients enrolled in SONICS, an open-label, phase 3 study of levoketoconazole as a treatment for endogenous Cushing’s disease (CD) that enrolled 94 patients at centers in North America, Europe and the Middle East. An investigational cortisol synthesis inhibitor, levoketoconazole is being developed by Strongbridge Biopharma and is not yet approved by the Food and Drug Administration.

“Despite the availability of approved treatments, the medical needs in Cushing’s [disease] remain very high,” the study’s principal investigator, Maria Fleseriu, MD, FACE, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists, where the data were presented. “This study demonstrates that levoketoconazole has the potential to address several clinical features of Cushing’s, owing to its clinically translated novel mechanism of action to suppress both cortisol and androgen syntheses (the latter elevated in many women with CD). Interestingly, there was no evidence of clinically important free-T reduction in men, and more studies are needed to elucidate this mechanism.”

In SONICS, adults with confirmed CD and mean 24-hour urinary free-cortisol (mUFC) value at least 1.5 times the upper limit of normal were treated with levoketoconazole in three phases: 2- to 21-week dose-titration phase (150-600 mg BID, as needed, to target mUFC normalization); 6-month maintenance phase (primary endpoint); and 6-month extended evaluation phase. The end of maintenance phase findings that focused on reductions in mUFC and safety had been previously reported. The current analysis focused on secondary endpoints, including changes from baseline to end of maintenance in investigator-assessed CD clinical signs and symptoms (acne score [range: 0-44]; hirsutism score [women only; range: 0-36]; and peripheral edema score [range: 0-12]), and patient-reported outcomes of quality of life (Cushing QoL questionnaire score [range: 0-100]) and depression (Beck Depression Inventory II score [range: 0-63]). The researchers also assessed hormones including free testosterone levels, and they used paired t-tests to infer statistical significance of the mean changes from baseline to end of maintenance for all measures.

Of the 94 patients enrolled in SONICS, 77 entered the maintenance phase, said Dr. Fleseriu, professor of medicine and neurological surgery and director of the pituitary center at Oregon Health and Science University, Portland. The patients’ mean age was 44 years and mean baseline mUFC was 243.3 mcg/day; 82% of patients were female, and 96% were white. Between baseline and the end of maintenance, the researchers observed significant mean improvements in acne scores (from 2.8 to –1.8, respectively; P = .0063), hirsutism scores (women only, from 7.8 to –2.6; P = .0008), and peripheral edema scores (from 1.0 to –0.4; P = .0295). They also observed significant mean improvements in quality of life and depression scores between baseline and end of maintenance (P less than .0001 and P = .0043, respectively). Mean free-testosterone levels increased nonsignificantly between baseline and end of maintenance in men (from 5.1 to 5.8 ng/dL) yet decreased significantly in women (from 0.3 to 0.1 ng/dL; P less than 0.0001; reference). Overall, 33 patients (35%) discontinued taking levoketoconazole by the end of the maintenance phase. Twelve (13%) discontinued because of adverse events.

“I wasn’t necessarily surprised with any of the data in this poster as I had experience with the drug in clinical trials, but I was definitely pleased to see overall significant improvements in acne score, hirsutism score in women, and peripheral edema score,” Dr. Fleseriu said. “Those are benefits that could potentially increase long-term adherence to treatment and quality-of-life improvements, particularly in women. It’s also exciting to see that quality of life and depression improved in these patients as well.”

These types of patient-reported outcomes are so important to how our patients feel about their disease and should be more of a focus for us physicians; it’s important to look at efficacy, safety and patient reported outcomes when we decide for an individualized treatment for each patient,” she noted.

Dr. Fleseriu reported that she has received research funding for Oregon Health and Science University from Novartis, Millendo, and Strongbridge. She has also received scientific consulting fees from Novartis and Strongbridge.

[email protected]

LOS ANGELES – Following 6 months of treatment with the investigational agent levoketoconazole, several clinical signs and symptoms of Cushing’s disease improved, including acne, hirsutism, and peripheral edema, as did patient-reported quality of life and symptoms of depression.

The findings come from an analysis of secondary endpoints among patients enrolled in SONICS, an open-label, phase 3 study of levoketoconazole as a treatment for endogenous Cushing’s disease (CD) that enrolled 94 patients at centers in North America, Europe and the Middle East. An investigational cortisol synthesis inhibitor, levoketoconazole is being developed by Strongbridge Biopharma and is not yet approved by the Food and Drug Administration.

“Despite the availability of approved treatments, the medical needs in Cushing’s [disease] remain very high,” the study’s principal investigator, Maria Fleseriu, MD, FACE, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists, where the data were presented. “This study demonstrates that levoketoconazole has the potential to address several clinical features of Cushing’s, owing to its clinically translated novel mechanism of action to suppress both cortisol and androgen syntheses (the latter elevated in many women with CD). Interestingly, there was no evidence of clinically important free-T reduction in men, and more studies are needed to elucidate this mechanism.”

In SONICS, adults with confirmed CD and mean 24-hour urinary free-cortisol (mUFC) value at least 1.5 times the upper limit of normal were treated with levoketoconazole in three phases: 2- to 21-week dose-titration phase (150-600 mg BID, as needed, to target mUFC normalization); 6-month maintenance phase (primary endpoint); and 6-month extended evaluation phase. The end of maintenance phase findings that focused on reductions in mUFC and safety had been previously reported. The current analysis focused on secondary endpoints, including changes from baseline to end of maintenance in investigator-assessed CD clinical signs and symptoms (acne score [range: 0-44]; hirsutism score [women only; range: 0-36]; and peripheral edema score [range: 0-12]), and patient-reported outcomes of quality of life (Cushing QoL questionnaire score [range: 0-100]) and depression (Beck Depression Inventory II score [range: 0-63]). The researchers also assessed hormones including free testosterone levels, and they used paired t-tests to infer statistical significance of the mean changes from baseline to end of maintenance for all measures.

Of the 94 patients enrolled in SONICS, 77 entered the maintenance phase, said Dr. Fleseriu, professor of medicine and neurological surgery and director of the pituitary center at Oregon Health and Science University, Portland. The patients’ mean age was 44 years and mean baseline mUFC was 243.3 mcg/day; 82% of patients were female, and 96% were white. Between baseline and the end of maintenance, the researchers observed significant mean improvements in acne scores (from 2.8 to –1.8, respectively; P = .0063), hirsutism scores (women only, from 7.8 to –2.6; P = .0008), and peripheral edema scores (from 1.0 to –0.4; P = .0295). They also observed significant mean improvements in quality of life and depression scores between baseline and end of maintenance (P less than .0001 and P = .0043, respectively). Mean free-testosterone levels increased nonsignificantly between baseline and end of maintenance in men (from 5.1 to 5.8 ng/dL) yet decreased significantly in women (from 0.3 to 0.1 ng/dL; P less than 0.0001; reference). Overall, 33 patients (35%) discontinued taking levoketoconazole by the end of the maintenance phase. Twelve (13%) discontinued because of adverse events.

“I wasn’t necessarily surprised with any of the data in this poster as I had experience with the drug in clinical trials, but I was definitely pleased to see overall significant improvements in acne score, hirsutism score in women, and peripheral edema score,” Dr. Fleseriu said. “Those are benefits that could potentially increase long-term adherence to treatment and quality-of-life improvements, particularly in women. It’s also exciting to see that quality of life and depression improved in these patients as well.”

These types of patient-reported outcomes are so important to how our patients feel about their disease and should be more of a focus for us physicians; it’s important to look at efficacy, safety and patient reported outcomes when we decide for an individualized treatment for each patient,” she noted.

Dr. Fleseriu reported that she has received research funding for Oregon Health and Science University from Novartis, Millendo, and Strongbridge. She has also received scientific consulting fees from Novartis and Strongbridge.

[email protected]

LOS ANGELES – Following 6 months of treatment with the investigational agent levoketoconazole, several clinical signs and symptoms of Cushing’s disease improved, including acne, hirsutism, and peripheral edema, as did patient-reported quality of life and symptoms of depression.

The findings come from an analysis of secondary endpoints among patients enrolled in SONICS, an open-label, phase 3 study of levoketoconazole as a treatment for endogenous Cushing’s disease (CD) that enrolled 94 patients at centers in North America, Europe and the Middle East. An investigational cortisol synthesis inhibitor, levoketoconazole is being developed by Strongbridge Biopharma and is not yet approved by the Food and Drug Administration.

“Despite the availability of approved treatments, the medical needs in Cushing’s [disease] remain very high,” the study’s principal investigator, Maria Fleseriu, MD, FACE, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists, where the data were presented. “This study demonstrates that levoketoconazole has the potential to address several clinical features of Cushing’s, owing to its clinically translated novel mechanism of action to suppress both cortisol and androgen syntheses (the latter elevated in many women with CD). Interestingly, there was no evidence of clinically important free-T reduction in men, and more studies are needed to elucidate this mechanism.”

In SONICS, adults with confirmed CD and mean 24-hour urinary free-cortisol (mUFC) value at least 1.5 times the upper limit of normal were treated with levoketoconazole in three phases: 2- to 21-week dose-titration phase (150-600 mg BID, as needed, to target mUFC normalization); 6-month maintenance phase (primary endpoint); and 6-month extended evaluation phase. The end of maintenance phase findings that focused on reductions in mUFC and safety had been previously reported. The current analysis focused on secondary endpoints, including changes from baseline to end of maintenance in investigator-assessed CD clinical signs and symptoms (acne score [range: 0-44]; hirsutism score [women only; range: 0-36]; and peripheral edema score [range: 0-12]), and patient-reported outcomes of quality of life (Cushing QoL questionnaire score [range: 0-100]) and depression (Beck Depression Inventory II score [range: 0-63]). The researchers also assessed hormones including free testosterone levels, and they used paired t-tests to infer statistical significance of the mean changes from baseline to end of maintenance for all measures.

Of the 94 patients enrolled in SONICS, 77 entered the maintenance phase, said Dr. Fleseriu, professor of medicine and neurological surgery and director of the pituitary center at Oregon Health and Science University, Portland. The patients’ mean age was 44 years and mean baseline mUFC was 243.3 mcg/day; 82% of patients were female, and 96% were white. Between baseline and the end of maintenance, the researchers observed significant mean improvements in acne scores (from 2.8 to –1.8, respectively; P = .0063), hirsutism scores (women only, from 7.8 to –2.6; P = .0008), and peripheral edema scores (from 1.0 to –0.4; P = .0295). They also observed significant mean improvements in quality of life and depression scores between baseline and end of maintenance (P less than .0001 and P = .0043, respectively). Mean free-testosterone levels increased nonsignificantly between baseline and end of maintenance in men (from 5.1 to 5.8 ng/dL) yet decreased significantly in women (from 0.3 to 0.1 ng/dL; P less than 0.0001; reference). Overall, 33 patients (35%) discontinued taking levoketoconazole by the end of the maintenance phase. Twelve (13%) discontinued because of adverse events.

“I wasn’t necessarily surprised with any of the data in this poster as I had experience with the drug in clinical trials, but I was definitely pleased to see overall significant improvements in acne score, hirsutism score in women, and peripheral edema score,” Dr. Fleseriu said. “Those are benefits that could potentially increase long-term adherence to treatment and quality-of-life improvements, particularly in women. It’s also exciting to see that quality of life and depression improved in these patients as well.”

These types of patient-reported outcomes are so important to how our patients feel about their disease and should be more of a focus for us physicians; it’s important to look at efficacy, safety and patient reported outcomes when we decide for an individualized treatment for each patient,” she noted.

Dr. Fleseriu reported that she has received research funding for Oregon Health and Science University from Novartis, Millendo, and Strongbridge. She has also received scientific consulting fees from Novartis and Strongbridge.

[email protected]

DENVER – An investigational 1726-nm laser with controlled air cooling and active thermal monitoring selectively damaged the sebaceous glands of acne patients without histologic disruption to the surrounding dermis, results from a small study showed.

“It is our belief that if we can destruct the sebaceous glands, it will cure acne,” Emil A. Tanghetti, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “High-dose red light PDT [photodynamic therapy] has been used, but it causes epidermal damage and an unacceptably long recovery time. Gold and silver nanoshells with infrared light have also been used. Usually these particles do not get into the sebaceous glands and appear to result in temporary improvement by wounding the infrainfundibular region of the sebaceous gland complex. It’s been shown that the 1726-nm light can target sebum and might be able to selectively damage sebaceous glands.”

Dr. Tanghetti, of the Sacramento-based Center for Dermatology and Laser Surgery, along with R. Rox Anderson, MD, and Fernanda H. Sakamoto, MD, PhD, of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, are studying a 1726-nm laser being developed by Accure. This device uses robust and precise air cooling, a creative pulsing strategy to enhance the differential sebum to water absorption, and active, real-time monitoring via thermal imaging.

“The device is constructed to turn off before an unsafe temperature is reached,” Dr. Tanghetti said. “The thermal camera is looking at the treatment site as it happening. If it gets too hot, it can turn the whole device off. You can only do real-time monitoring with air cooling. You cannot do it with contract cooling or cryogen cooling.”


In a study of 10 patients with acne, the researchers developed a multiple pulse strategy to slowly and preferentially heat sebaceous glands while sparing the epidermis and the surrounding dermis. They performed 3.5-mm punch biopsies at 24, 48, and 72 hours after treatment, and evaluated them with hematoxylin and eosin staining.

From a clinical standpoint, Dr. Tanghetti and his colleagues noted small papules in the treated areas immediately, 24 hours and 72 hours after treatment. “You don’t see the epidermal damage that you would see with someone who had PDT,” he said.

Histologic evaluation of tissue specimens at 24 and 72 hours revealed destruction of sebaceous glands in the dermis characterized by loss of the definition of the sebocytes, and eosinophilic changes of the basal cell layer of these glands. The collagen surrounding the gland appeared to be preserved, with occasional small clots observed in the adjacent blood vessels. “There was no obvious damage to the surrounding dermis or other follicular structures,” Dr. Tanghetti said. “The hard thing is to differentiate complete damage [of the sebaceous gland] from partial damage. That’s something we’re working on by looking at sebum production, which is going to be the ultimate outcome.”

The study authors reported having numerous financial ties to medical device and pharmaceutical companies.

[email protected]

DENVER – An investigational 1726-nm laser with controlled air cooling and active thermal monitoring selectively damaged the sebaceous glands of acne patients without histologic disruption to the surrounding dermis, results from a small study showed.

“It is our belief that if we can destruct the sebaceous glands, it will cure acne,” Emil A. Tanghetti, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “High-dose red light PDT [photodynamic therapy] has been used, but it causes epidermal damage and an unacceptably long recovery time. Gold and silver nanoshells with infrared light have also been used. Usually these particles do not get into the sebaceous glands and appear to result in temporary improvement by wounding the infrainfundibular region of the sebaceous gland complex. It’s been shown that the 1726-nm light can target sebum and might be able to selectively damage sebaceous glands.”

Dr. Tanghetti, of the Sacramento-based Center for Dermatology and Laser Surgery, along with R. Rox Anderson, MD, and Fernanda H. Sakamoto, MD, PhD, of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, are studying a 1726-nm laser being developed by Accure. This device uses robust and precise air cooling, a creative pulsing strategy to enhance the differential sebum to water absorption, and active, real-time monitoring via thermal imaging.

“The device is constructed to turn off before an unsafe temperature is reached,” Dr. Tanghetti said. “The thermal camera is looking at the treatment site as it happening. If it gets too hot, it can turn the whole device off. You can only do real-time monitoring with air cooling. You cannot do it with contract cooling or cryogen cooling.”


In a study of 10 patients with acne, the researchers developed a multiple pulse strategy to slowly and preferentially heat sebaceous glands while sparing the epidermis and the surrounding dermis. They performed 3.5-mm punch biopsies at 24, 48, and 72 hours after treatment, and evaluated them with hematoxylin and eosin staining.

From a clinical standpoint, Dr. Tanghetti and his colleagues noted small papules in the treated areas immediately, 24 hours and 72 hours after treatment. “You don’t see the epidermal damage that you would see with someone who had PDT,” he said.

Histologic evaluation of tissue specimens at 24 and 72 hours revealed destruction of sebaceous glands in the dermis characterized by loss of the definition of the sebocytes, and eosinophilic changes of the basal cell layer of these glands. The collagen surrounding the gland appeared to be preserved, with occasional small clots observed in the adjacent blood vessels. “There was no obvious damage to the surrounding dermis or other follicular structures,” Dr. Tanghetti said. “The hard thing is to differentiate complete damage [of the sebaceous gland] from partial damage. That’s something we’re working on by looking at sebum production, which is going to be the ultimate outcome.”

The study authors reported having numerous financial ties to medical device and pharmaceutical companies.

[email protected]

DENVER – An investigational 1726-nm laser with controlled air cooling and active thermal monitoring selectively damaged the sebaceous glands of acne patients without histologic disruption to the surrounding dermis, results from a small study showed.

“It is our belief that if we can destruct the sebaceous glands, it will cure acne,” Emil A. Tanghetti, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “High-dose red light PDT [photodynamic therapy] has been used, but it causes epidermal damage and an unacceptably long recovery time. Gold and silver nanoshells with infrared light have also been used. Usually these particles do not get into the sebaceous glands and appear to result in temporary improvement by wounding the infrainfundibular region of the sebaceous gland complex. It’s been shown that the 1726-nm light can target sebum and might be able to selectively damage sebaceous glands.”

Dr. Tanghetti, of the Sacramento-based Center for Dermatology and Laser Surgery, along with R. Rox Anderson, MD, and Fernanda H. Sakamoto, MD, PhD, of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, are studying a 1726-nm laser being developed by Accure. This device uses robust and precise air cooling, a creative pulsing strategy to enhance the differential sebum to water absorption, and active, real-time monitoring via thermal imaging.

“The device is constructed to turn off before an unsafe temperature is reached,” Dr. Tanghetti said. “The thermal camera is looking at the treatment site as it happening. If it gets too hot, it can turn the whole device off. You can only do real-time monitoring with air cooling. You cannot do it with contract cooling or cryogen cooling.”


In a study of 10 patients with acne, the researchers developed a multiple pulse strategy to slowly and preferentially heat sebaceous glands while sparing the epidermis and the surrounding dermis. They performed 3.5-mm punch biopsies at 24, 48, and 72 hours after treatment, and evaluated them with hematoxylin and eosin staining.

From a clinical standpoint, Dr. Tanghetti and his colleagues noted small papules in the treated areas immediately, 24 hours and 72 hours after treatment. “You don’t see the epidermal damage that you would see with someone who had PDT,” he said.

Histologic evaluation of tissue specimens at 24 and 72 hours revealed destruction of sebaceous glands in the dermis characterized by loss of the definition of the sebocytes, and eosinophilic changes of the basal cell layer of these glands. The collagen surrounding the gland appeared to be preserved, with occasional small clots observed in the adjacent blood vessels. “There was no obvious damage to the surrounding dermis or other follicular structures,” Dr. Tanghetti said. “The hard thing is to differentiate complete damage [of the sebaceous gland] from partial damage. That’s something we’re working on by looking at sebum production, which is going to be the ultimate outcome.”

The study authors reported having numerous financial ties to medical device and pharmaceutical companies.

[email protected]

DENVER – In the opinion of Jeremy A. Brauer, MD, the best way to prevent complications in resurfacing skin of color is to make sure that you’ve selected the proper patient to treat.

“You have to have the right patients and the right indication,” Dr. Brauer said at the annual conference of the American Society for Laser Medicine and Surgery. “What are they coming in for? Are they asking for what they really need?”

Taking a thorough medical history during consultations and follow-up visits is also key. “What medical or surgical problems do they have?” he asked. “Do they have a history of keloid formation? Are they on isotretinoin? What allergies do they have? What are their expectations, and are they realistic? For example, do they believe that you are going to erase all of their acne scars? On physical exam, be sure that what you’re looking at is what they’re concerned about, so that you agree upon what can and can’t be effectively treated.”

Above all else, stay true to your gut. “If you perceive that someone is not a suitable candidate for resurfacing or has unrealistic expectations, and they are insistent, it is important to stand your ground, and even find a way to politely walk away,” said Dr. Brauer of the department of dermatology at New York University.


Most complications from laser resurfacing are not unique to skin of color, he continued. A review of the topic revealed that mild complications may include prolonged erythema, acne and milia, delayed purpura, superficial erosions, contact dermatitis, and recall phenomenon (Dermatol Surg. 2010;36[3]:299-306). Moderate complications may include infection, pigmentary alteration, anesthesia toxicity, and eruptive keratoacanthomas, while severe complications may include hypertrophic scarring, ectropion formation, and disseminated infection.

An earlier analysis of fractional laser treatment found that patients with darker skin types had a significantly higher proportion of certain side effects, namely postinflammatory hyperpigmentation (Dermatol Surg. 2008;34[3]:301-7). “Additionally, the researchers found that this presented both later and lasted longer than in individuals with lighter skin types,” said Dr. Brauer, who was not involved with the study.

He listed pigmentary alterations and hypertrophic scarring/keloid formation as the potential complications from resurfacing to be most concerned about in skin of color patients. “In addition to appropriate device selection, the correct device parameters are key,” he said. “You have to make sure you use appropriate energy, but you can use higher energies with lower densities to minimize the risk of postinflammatory pigmentation. You also want to protect the epidermis by use of epidermal cooling, avoid bulk heating, and perform sessions at prolonged treatment intervals, to safely achieve optimal results.”

Dr. Brauer reported having received honoraria or being a member of the medical advisory board for Cutera, Cynosure/Hologic, and Merz. 

[email protected]

DENVER – In the opinion of Jeremy A. Brauer, MD, the best way to prevent complications in resurfacing skin of color is to make sure that you’ve selected the proper patient to treat.

“You have to have the right patients and the right indication,” Dr. Brauer said at the annual conference of the American Society for Laser Medicine and Surgery. “What are they coming in for? Are they asking for what they really need?”

Taking a thorough medical history during consultations and follow-up visits is also key. “What medical or surgical problems do they have?” he asked. “Do they have a history of keloid formation? Are they on isotretinoin? What allergies do they have? What are their expectations, and are they realistic? For example, do they believe that you are going to erase all of their acne scars? On physical exam, be sure that what you’re looking at is what they’re concerned about, so that you agree upon what can and can’t be effectively treated.”

Above all else, stay true to your gut. “If you perceive that someone is not a suitable candidate for resurfacing or has unrealistic expectations, and they are insistent, it is important to stand your ground, and even find a way to politely walk away,” said Dr. Brauer of the department of dermatology at New York University.


Most complications from laser resurfacing are not unique to skin of color, he continued. A review of the topic revealed that mild complications may include prolonged erythema, acne and milia, delayed purpura, superficial erosions, contact dermatitis, and recall phenomenon (Dermatol Surg. 2010;36[3]:299-306). Moderate complications may include infection, pigmentary alteration, anesthesia toxicity, and eruptive keratoacanthomas, while severe complications may include hypertrophic scarring, ectropion formation, and disseminated infection.

An earlier analysis of fractional laser treatment found that patients with darker skin types had a significantly higher proportion of certain side effects, namely postinflammatory hyperpigmentation (Dermatol Surg. 2008;34[3]:301-7). “Additionally, the researchers found that this presented both later and lasted longer than in individuals with lighter skin types,” said Dr. Brauer, who was not involved with the study.

He listed pigmentary alterations and hypertrophic scarring/keloid formation as the potential complications from resurfacing to be most concerned about in skin of color patients. “In addition to appropriate device selection, the correct device parameters are key,” he said. “You have to make sure you use appropriate energy, but you can use higher energies with lower densities to minimize the risk of postinflammatory pigmentation. You also want to protect the epidermis by use of epidermal cooling, avoid bulk heating, and perform sessions at prolonged treatment intervals, to safely achieve optimal results.”

Dr. Brauer reported having received honoraria or being a member of the medical advisory board for Cutera, Cynosure/Hologic, and Merz. 

[email protected]

DENVER – In the opinion of Jeremy A. Brauer, MD, the best way to prevent complications in resurfacing skin of color is to make sure that you’ve selected the proper patient to treat.

“You have to have the right patients and the right indication,” Dr. Brauer said at the annual conference of the American Society for Laser Medicine and Surgery. “What are they coming in for? Are they asking for what they really need?”

Taking a thorough medical history during consultations and follow-up visits is also key. “What medical or surgical problems do they have?” he asked. “Do they have a history of keloid formation? Are they on isotretinoin? What allergies do they have? What are their expectations, and are they realistic? For example, do they believe that you are going to erase all of their acne scars? On physical exam, be sure that what you’re looking at is what they’re concerned about, so that you agree upon what can and can’t be effectively treated.”

Above all else, stay true to your gut. “If you perceive that someone is not a suitable candidate for resurfacing or has unrealistic expectations, and they are insistent, it is important to stand your ground, and even find a way to politely walk away,” said Dr. Brauer of the department of dermatology at New York University.


Most complications from laser resurfacing are not unique to skin of color, he continued. A review of the topic revealed that mild complications may include prolonged erythema, acne and milia, delayed purpura, superficial erosions, contact dermatitis, and recall phenomenon (Dermatol Surg. 2010;36[3]:299-306). Moderate complications may include infection, pigmentary alteration, anesthesia toxicity, and eruptive keratoacanthomas, while severe complications may include hypertrophic scarring, ectropion formation, and disseminated infection.

An earlier analysis of fractional laser treatment found that patients with darker skin types had a significantly higher proportion of certain side effects, namely postinflammatory hyperpigmentation (Dermatol Surg. 2008;34[3]:301-7). “Additionally, the researchers found that this presented both later and lasted longer than in individuals with lighter skin types,” said Dr. Brauer, who was not involved with the study.

He listed pigmentary alterations and hypertrophic scarring/keloid formation as the potential complications from resurfacing to be most concerned about in skin of color patients. “In addition to appropriate device selection, the correct device parameters are key,” he said. “You have to make sure you use appropriate energy, but you can use higher energies with lower densities to minimize the risk of postinflammatory pigmentation. You also want to protect the epidermis by use of epidermal cooling, avoid bulk heating, and perform sessions at prolonged treatment intervals, to safely achieve optimal results.”

Dr. Brauer reported having received honoraria or being a member of the medical advisory board for Cutera, Cynosure/Hologic, and Merz. 

[email protected]

DENVER – The fractionated picosecond Nd:YAG laser and fractionated thulium fiber laser can be equally effective for facial rejuvenation, results from a small split-face trial showed. However, the fractionated picosecond Nd:YAG laser may result in significantly less postoperative downtime, compared with the fractionated thulium fiber laser.

The findings from the prospective, evaluator-blinded trial were presented by Douglas C. Wu, MD, PhD, at the annual conference of the American Society for Laser Medicine and Surgery. Dr. Wu, of San Diego–based Cosmetic Laser Dermatology, and his colleague, Mitchel P. Goldman, MD, enrolled 20 subjects with at least moderate photoaging who randomly received three treatments with either the 1064/532-nm fractionated picosecond Nd:YAG laser or with the 1927-nm fractionated thulium fiber laser on each side of the face, 4 weeks apart. The primary endpoint was the degree of rhytids, laxity, dyschromia, erythema-telangiectasia, keratoses, and texture rated on a four-point scale and performed by a blinded evaluator at baseline, and 12, 20, and 30 weeks from baseline. Secondary endpoints were the global aesthetic improvement score, investigator satisfaction questionnaire, and a subject satisfaction questionnaire administered at weeks 12, 20, and 30. Recovery time and adverse events were assessed through a 14-day subject diary administered after each treatment.


All but 1 of the 20 patients were female and their mean age was 57 years. Six had Fitzpatrick skin type II, seven had type III, six had type IV, and one had type V. The device settings were on medium for both devices. The researchers observed significant improvements in elastosis, erythema, dyschromia, and texture at all treatment follow-up time points (P less than .01 for all endpoints).

There were no differences between the two lasers in terms of efficacy. “Clinically, the efficacy was rated to be the same,” Dr. Wu said. “However, when we analyzed the patient diaries, we found some very interesting results. In terms of redness, at days 3 and 4, there was a consistently increased amount of redness on the side treated with the fractionated thulium fiber laser, with swelling also being significantly increased at day 5.” Similarly, he said, the side treated with the fractionated picosecond laser experienced significantly less crusting on posttreatment days 1 through 9, less peeling on days 3 through 5, and less itching on day 4. Posttreatment pain was minimal on both sides and did not differ significantly.

Dr. Wu disclosed having numerous financial ties to pharmaceutical and device companies.

[email protected]

DENVER – The fractionated picosecond Nd:YAG laser and fractionated thulium fiber laser can be equally effective for facial rejuvenation, results from a small split-face trial showed. However, the fractionated picosecond Nd:YAG laser may result in significantly less postoperative downtime, compared with the fractionated thulium fiber laser.

The findings from the prospective, evaluator-blinded trial were presented by Douglas C. Wu, MD, PhD, at the annual conference of the American Society for Laser Medicine and Surgery. Dr. Wu, of San Diego–based Cosmetic Laser Dermatology, and his colleague, Mitchel P. Goldman, MD, enrolled 20 subjects with at least moderate photoaging who randomly received three treatments with either the 1064/532-nm fractionated picosecond Nd:YAG laser or with the 1927-nm fractionated thulium fiber laser on each side of the face, 4 weeks apart. The primary endpoint was the degree of rhytids, laxity, dyschromia, erythema-telangiectasia, keratoses, and texture rated on a four-point scale and performed by a blinded evaluator at baseline, and 12, 20, and 30 weeks from baseline. Secondary endpoints were the global aesthetic improvement score, investigator satisfaction questionnaire, and a subject satisfaction questionnaire administered at weeks 12, 20, and 30. Recovery time and adverse events were assessed through a 14-day subject diary administered after each treatment.


All but 1 of the 20 patients were female and their mean age was 57 years. Six had Fitzpatrick skin type II, seven had type III, six had type IV, and one had type V. The device settings were on medium for both devices. The researchers observed significant improvements in elastosis, erythema, dyschromia, and texture at all treatment follow-up time points (P less than .01 for all endpoints).

There were no differences between the two lasers in terms of efficacy. “Clinically, the efficacy was rated to be the same,” Dr. Wu said. “However, when we analyzed the patient diaries, we found some very interesting results. In terms of redness, at days 3 and 4, there was a consistently increased amount of redness on the side treated with the fractionated thulium fiber laser, with swelling also being significantly increased at day 5.” Similarly, he said, the side treated with the fractionated picosecond laser experienced significantly less crusting on posttreatment days 1 through 9, less peeling on days 3 through 5, and less itching on day 4. Posttreatment pain was minimal on both sides and did not differ significantly.

Dr. Wu disclosed having numerous financial ties to pharmaceutical and device companies.

[email protected]

DENVER – The fractionated picosecond Nd:YAG laser and fractionated thulium fiber laser can be equally effective for facial rejuvenation, results from a small split-face trial showed. However, the fractionated picosecond Nd:YAG laser may result in significantly less postoperative downtime, compared with the fractionated thulium fiber laser.

The findings from the prospective, evaluator-blinded trial were presented by Douglas C. Wu, MD, PhD, at the annual conference of the American Society for Laser Medicine and Surgery. Dr. Wu, of San Diego–based Cosmetic Laser Dermatology, and his colleague, Mitchel P. Goldman, MD, enrolled 20 subjects with at least moderate photoaging who randomly received three treatments with either the 1064/532-nm fractionated picosecond Nd:YAG laser or with the 1927-nm fractionated thulium fiber laser on each side of the face, 4 weeks apart. The primary endpoint was the degree of rhytids, laxity, dyschromia, erythema-telangiectasia, keratoses, and texture rated on a four-point scale and performed by a blinded evaluator at baseline, and 12, 20, and 30 weeks from baseline. Secondary endpoints were the global aesthetic improvement score, investigator satisfaction questionnaire, and a subject satisfaction questionnaire administered at weeks 12, 20, and 30. Recovery time and adverse events were assessed through a 14-day subject diary administered after each treatment.


All but 1 of the 20 patients were female and their mean age was 57 years. Six had Fitzpatrick skin type II, seven had type III, six had type IV, and one had type V. The device settings were on medium for both devices. The researchers observed significant improvements in elastosis, erythema, dyschromia, and texture at all treatment follow-up time points (P less than .01 for all endpoints).

There were no differences between the two lasers in terms of efficacy. “Clinically, the efficacy was rated to be the same,” Dr. Wu said. “However, when we analyzed the patient diaries, we found some very interesting results. In terms of redness, at days 3 and 4, there was a consistently increased amount of redness on the side treated with the fractionated thulium fiber laser, with swelling also being significantly increased at day 5.” Similarly, he said, the side treated with the fractionated picosecond laser experienced significantly less crusting on posttreatment days 1 through 9, less peeling on days 3 through 5, and less itching on day 4. Posttreatment pain was minimal on both sides and did not differ significantly.

Dr. Wu disclosed having numerous financial ties to pharmaceutical and device companies.

[email protected]

DENVER – Among patients with facial erythema associated with erythrotelangiectatic rosacea, combining a long-pulsed 532 nm laser with daily application of a topical skin care regimen achieved equivalent to superior results in fewer treatments, compared with long-pulsed laser treatment alone.

The findings come from a pilot trial that Brian S. Biesman, MD, presented at the annual conference of the American Society for Laser Medicine and Surgery.

“Vascular laser therapy is the standard of care for reduction of facial erythema associated with erythrotelangiectatic rosacea,” said Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn. “The question was, if we combine topicals plus laser, can we get an enhanced outcome relative to laser treatment alone?”

To find out, he and his colleagues conducted a blinded, controlled prospective study of 30 subjects with mild to moderate erythrotelangiectatic rosacea who were evenly split into two groups. Those in group 1 received three treatments with the Excel V 532 nm long-pulsed laser by Cutera. Those in group 2 received two laser treatments with the Excel V long-pulsed 532 nm long-pulsed laser plus concurrent daily use of the topical Jan Marini Skin Care Management System, which included a glycolic acid cleanser, vitamin C serum, active containing glycolic, salicylic and azelaic acids, peptide, and growth factor moisturizer and a broad-spectrum sunscreen. It also contained RosaLieve, a proprietary redness-reducing complex.

The researchers performed laser treatments at 4-week intervals and evaluated subjects at baseline, 4, 8, and 12 weeks by physician and subject self-assessment using 5-point (0-4) standardized scales: the Clinician Erythema Assessment (CEA) and patient self-assessment as well as a dermatology Quality of Life Assessment. In both treatment groups, reduction in facial erythema as assessed by CEA and patient self-assessment showed statistically significant improvement at all measured intervals. Specifically, average CEA scores improved from 3.00 to 1.87 among patients in group 1, and from 3.07 to 1.64 among those in group 2. “These were both statistically significant from baseline,” Dr. Biesman said. “What does it really say? The laser plus topical was superior to the laser-only treatment at all measured intervals. I didn’t expect to see that. There was continued improvement noted from week 8 to week 12. That was more of a trend; it was not statistically significant. There were no complications or adverse reactions in either group. The study data indicate that best results may be achieved with a combination of laser and home care.”

He acknowledged certain limitations of the study, including its small sample size and relatively short course of follow-up. “We didn’t have standardization of topical therapy in the laser-only group,” Dr. Biesman said. “Those patients were told to use their usual topical regimen. They were not allowed to use retinoids. We also didn’t have a control arm.”

He disclosed that he has received grant funding from Jan Marini Skin Research and Cutera.

[email protected]

DENVER – Among patients with facial erythema associated with erythrotelangiectatic rosacea, combining a long-pulsed 532 nm laser with daily application of a topical skin care regimen achieved equivalent to superior results in fewer treatments, compared with long-pulsed laser treatment alone.

The findings come from a pilot trial that Brian S. Biesman, MD, presented at the annual conference of the American Society for Laser Medicine and Surgery.

“Vascular laser therapy is the standard of care for reduction of facial erythema associated with erythrotelangiectatic rosacea,” said Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn. “The question was, if we combine topicals plus laser, can we get an enhanced outcome relative to laser treatment alone?”

To find out, he and his colleagues conducted a blinded, controlled prospective study of 30 subjects with mild to moderate erythrotelangiectatic rosacea who were evenly split into two groups. Those in group 1 received three treatments with the Excel V 532 nm long-pulsed laser by Cutera. Those in group 2 received two laser treatments with the Excel V long-pulsed 532 nm long-pulsed laser plus concurrent daily use of the topical Jan Marini Skin Care Management System, which included a glycolic acid cleanser, vitamin C serum, active containing glycolic, salicylic and azelaic acids, peptide, and growth factor moisturizer and a broad-spectrum sunscreen. It also contained RosaLieve, a proprietary redness-reducing complex.

The researchers performed laser treatments at 4-week intervals and evaluated subjects at baseline, 4, 8, and 12 weeks by physician and subject self-assessment using 5-point (0-4) standardized scales: the Clinician Erythema Assessment (CEA) and patient self-assessment as well as a dermatology Quality of Life Assessment. In both treatment groups, reduction in facial erythema as assessed by CEA and patient self-assessment showed statistically significant improvement at all measured intervals. Specifically, average CEA scores improved from 3.00 to 1.87 among patients in group 1, and from 3.07 to 1.64 among those in group 2. “These were both statistically significant from baseline,” Dr. Biesman said. “What does it really say? The laser plus topical was superior to the laser-only treatment at all measured intervals. I didn’t expect to see that. There was continued improvement noted from week 8 to week 12. That was more of a trend; it was not statistically significant. There were no complications or adverse reactions in either group. The study data indicate that best results may be achieved with a combination of laser and home care.”

He acknowledged certain limitations of the study, including its small sample size and relatively short course of follow-up. “We didn’t have standardization of topical therapy in the laser-only group,” Dr. Biesman said. “Those patients were told to use their usual topical regimen. They were not allowed to use retinoids. We also didn’t have a control arm.”

He disclosed that he has received grant funding from Jan Marini Skin Research and Cutera.

[email protected]

DENVER – Among patients with facial erythema associated with erythrotelangiectatic rosacea, combining a long-pulsed 532 nm laser with daily application of a topical skin care regimen achieved equivalent to superior results in fewer treatments, compared with long-pulsed laser treatment alone.

The findings come from a pilot trial that Brian S. Biesman, MD, presented at the annual conference of the American Society for Laser Medicine and Surgery.

“Vascular laser therapy is the standard of care for reduction of facial erythema associated with erythrotelangiectatic rosacea,” said Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn. “The question was, if we combine topicals plus laser, can we get an enhanced outcome relative to laser treatment alone?”

To find out, he and his colleagues conducted a blinded, controlled prospective study of 30 subjects with mild to moderate erythrotelangiectatic rosacea who were evenly split into two groups. Those in group 1 received three treatments with the Excel V 532 nm long-pulsed laser by Cutera. Those in group 2 received two laser treatments with the Excel V long-pulsed 532 nm long-pulsed laser plus concurrent daily use of the topical Jan Marini Skin Care Management System, which included a glycolic acid cleanser, vitamin C serum, active containing glycolic, salicylic and azelaic acids, peptide, and growth factor moisturizer and a broad-spectrum sunscreen. It also contained RosaLieve, a proprietary redness-reducing complex.

The researchers performed laser treatments at 4-week intervals and evaluated subjects at baseline, 4, 8, and 12 weeks by physician and subject self-assessment using 5-point (0-4) standardized scales: the Clinician Erythema Assessment (CEA) and patient self-assessment as well as a dermatology Quality of Life Assessment. In both treatment groups, reduction in facial erythema as assessed by CEA and patient self-assessment showed statistically significant improvement at all measured intervals. Specifically, average CEA scores improved from 3.00 to 1.87 among patients in group 1, and from 3.07 to 1.64 among those in group 2. “These were both statistically significant from baseline,” Dr. Biesman said. “What does it really say? The laser plus topical was superior to the laser-only treatment at all measured intervals. I didn’t expect to see that. There was continued improvement noted from week 8 to week 12. That was more of a trend; it was not statistically significant. There were no complications or adverse reactions in either group. The study data indicate that best results may be achieved with a combination of laser and home care.”

He acknowledged certain limitations of the study, including its small sample size and relatively short course of follow-up. “We didn’t have standardization of topical therapy in the laser-only group,” Dr. Biesman said. “Those patients were told to use their usual topical regimen. They were not allowed to use retinoids. We also didn’t have a control arm.”

He disclosed that he has received grant funding from Jan Marini Skin Research and Cutera.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

DENVER – A survey from a dermatology practice in Houston found that among patients seeking corrective treatment for laser tattoo removal, 79% had complications from previous removal attempts and 63% were treated in non-clinic facilities by a non-physician provider without physician supervision.

The findings come from a single-center study that sought to identify the type, burden, and frequency of complications from laser tattoo removal, a procedure offered by both physician and non-physician facilities. “Laser tattoo removal is increasing in popularity,” lead study author Amanda K. Suggs, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Suggs and Paul M. Friedman, MD, of Houston-based Dermatology and Laser Surgery, have observed an increase in patients seeking corrective tattoo removal after complications from and lack of efficacy of prior treatments provided predominantly at non-clinic facilities, including medical spas and tattoo removal clinics –so they decided to interview 19 patients who presented to their practice seeking corrective laser tattoo removal. The majority (84%) were female, their mean age was 34 years old, and 53% had Fitzpatrick skin types IV or higher. Nearly three-quarters of tattoos (74%) consisted of multiple colors, which are known to be more difficult to treat. Of the patients seeking corrective treatment, 42% were seeking removal of more than one tattoo.

Prior to coming to their office, the patients had undergone an average of seven prior tattoo removal treatments and 72% of patients were treated by a non-physician provider at some point. Nearly two-thirds of patients (63%) were treated in non-clinic facilities. “All patients were unsatisfied with the degree of improvement, and 79% had at least one complication from their prior treatments,” said Dr. Suggs, who is a fellow at the practice.

Of the 15 patients with prior treatment complications, 64% were treated by a non-physician provider. The most common complication was scarring (53%), followed by dyspigmentation (47%), blistering (20%) and paradoxical darkening (20%). Six patients (40%) had more than one complication. Patients with Fitzpatrick skin types IV or higher had a higher proportion of scarring and dyspigmentation (63% and 71%, respectively) compared with those with other skin types. “This suggests that we should use caution when treating tattoos in patients with higher Fitzpatrick skin types, and use appropriate settings and endpoints when treating these patients,” Dr. Suggs said.


When she and Dr. Friedman interviewed the patients about their prior treatment experience elsewhere, all said they experienced excessive pain, only 33% received topical anesthesia, and none reported receiving an injectable anesthesia.

At the Dermatology and Laser Surgery Center, the protocol for corrective laser tattoo removal involves injectable anesthesia, Dr. Suggs said. They use a picosecond laser, a perfluorodecalin patch, and, if needed, nonablative fractional resurfacing at 1550 nm for scarring. The wavelength used for the picosecond laser (1064nm, 785nm or 532nm) is chosen based on patient characteristics and tattoo color or colors.

Lance Sitton Photography/Thinkstock

In a subset analysis, the investigators interviewed eight patients again after undergoing laser tattoo removal at their practice. All underwent treatment with a picosecond laser, perfluorodecalin patch, and injectable anesthesia. All reported minimal to no pain during the procedure and an optimal experience. No complications were noted.

Dr. Friedman and Dr. Suggs emphasized that consumers should be aware of the risks and potential for complications from laser tattoo removal. They recommend that all consumers – especially those at higher risk for complications such as higher Fitzpatrick skin type patients and those with multicolored tattoos – choose a provider with extensive training in the procedure, such as a board-certified dermatologist or plastic surgeon.

Dr. Suggs disclosed that she is an ambassador for Tri Sirena sun protective athletic apparel. Dr. Friedman disclosed that he is a member of the advisory board for Allergan, Solta Medical, Syneron-Candela, and Sienna Biopharmaceuticals. He is also a research investigator for Syneron-Candela and has received a research grant from Sienna.

[email protected]

DENVER – A survey from a dermatology practice in Houston found that among patients seeking corrective treatment for laser tattoo removal, 79% had complications from previous removal attempts and 63% were treated in non-clinic facilities by a non-physician provider without physician supervision.

The findings come from a single-center study that sought to identify the type, burden, and frequency of complications from laser tattoo removal, a procedure offered by both physician and non-physician facilities. “Laser tattoo removal is increasing in popularity,” lead study author Amanda K. Suggs, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Suggs and Paul M. Friedman, MD, of Houston-based Dermatology and Laser Surgery, have observed an increase in patients seeking corrective tattoo removal after complications from and lack of efficacy of prior treatments provided predominantly at non-clinic facilities, including medical spas and tattoo removal clinics –so they decided to interview 19 patients who presented to their practice seeking corrective laser tattoo removal. The majority (84%) were female, their mean age was 34 years old, and 53% had Fitzpatrick skin types IV or higher. Nearly three-quarters of tattoos (74%) consisted of multiple colors, which are known to be more difficult to treat. Of the patients seeking corrective treatment, 42% were seeking removal of more than one tattoo.

Prior to coming to their office, the patients had undergone an average of seven prior tattoo removal treatments and 72% of patients were treated by a non-physician provider at some point. Nearly two-thirds of patients (63%) were treated in non-clinic facilities. “All patients were unsatisfied with the degree of improvement, and 79% had at least one complication from their prior treatments,” said Dr. Suggs, who is a fellow at the practice.

Of the 15 patients with prior treatment complications, 64% were treated by a non-physician provider. The most common complication was scarring (53%), followed by dyspigmentation (47%), blistering (20%) and paradoxical darkening (20%). Six patients (40%) had more than one complication. Patients with Fitzpatrick skin types IV or higher had a higher proportion of scarring and dyspigmentation (63% and 71%, respectively) compared with those with other skin types. “This suggests that we should use caution when treating tattoos in patients with higher Fitzpatrick skin types, and use appropriate settings and endpoints when treating these patients,” Dr. Suggs said.


When she and Dr. Friedman interviewed the patients about their prior treatment experience elsewhere, all said they experienced excessive pain, only 33% received topical anesthesia, and none reported receiving an injectable anesthesia.

At the Dermatology and Laser Surgery Center, the protocol for corrective laser tattoo removal involves injectable anesthesia, Dr. Suggs said. They use a picosecond laser, a perfluorodecalin patch, and, if needed, nonablative fractional resurfacing at 1550 nm for scarring. The wavelength used for the picosecond laser (1064nm, 785nm or 532nm) is chosen based on patient characteristics and tattoo color or colors.

Lance Sitton Photography/Thinkstock

In a subset analysis, the investigators interviewed eight patients again after undergoing laser tattoo removal at their practice. All underwent treatment with a picosecond laser, perfluorodecalin patch, and injectable anesthesia. All reported minimal to no pain during the procedure and an optimal experience. No complications were noted.

Dr. Friedman and Dr. Suggs emphasized that consumers should be aware of the risks and potential for complications from laser tattoo removal. They recommend that all consumers – especially those at higher risk for complications such as higher Fitzpatrick skin type patients and those with multicolored tattoos – choose a provider with extensive training in the procedure, such as a board-certified dermatologist or plastic surgeon.

Dr. Suggs disclosed that she is an ambassador for Tri Sirena sun protective athletic apparel. Dr. Friedman disclosed that he is a member of the advisory board for Allergan, Solta Medical, Syneron-Candela, and Sienna Biopharmaceuticals. He is also a research investigator for Syneron-Candela and has received a research grant from Sienna.

[email protected]

DENVER – A survey from a dermatology practice in Houston found that among patients seeking corrective treatment for laser tattoo removal, 79% had complications from previous removal attempts and 63% were treated in non-clinic facilities by a non-physician provider without physician supervision.

The findings come from a single-center study that sought to identify the type, burden, and frequency of complications from laser tattoo removal, a procedure offered by both physician and non-physician facilities. “Laser tattoo removal is increasing in popularity,” lead study author Amanda K. Suggs, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Suggs and Paul M. Friedman, MD, of Houston-based Dermatology and Laser Surgery, have observed an increase in patients seeking corrective tattoo removal after complications from and lack of efficacy of prior treatments provided predominantly at non-clinic facilities, including medical spas and tattoo removal clinics –so they decided to interview 19 patients who presented to their practice seeking corrective laser tattoo removal. The majority (84%) were female, their mean age was 34 years old, and 53% had Fitzpatrick skin types IV or higher. Nearly three-quarters of tattoos (74%) consisted of multiple colors, which are known to be more difficult to treat. Of the patients seeking corrective treatment, 42% were seeking removal of more than one tattoo.

Prior to coming to their office, the patients had undergone an average of seven prior tattoo removal treatments and 72% of patients were treated by a non-physician provider at some point. Nearly two-thirds of patients (63%) were treated in non-clinic facilities. “All patients were unsatisfied with the degree of improvement, and 79% had at least one complication from their prior treatments,” said Dr. Suggs, who is a fellow at the practice.

Of the 15 patients with prior treatment complications, 64% were treated by a non-physician provider. The most common complication was scarring (53%), followed by dyspigmentation (47%), blistering (20%) and paradoxical darkening (20%). Six patients (40%) had more than one complication. Patients with Fitzpatrick skin types IV or higher had a higher proportion of scarring and dyspigmentation (63% and 71%, respectively) compared with those with other skin types. “This suggests that we should use caution when treating tattoos in patients with higher Fitzpatrick skin types, and use appropriate settings and endpoints when treating these patients,” Dr. Suggs said.


When she and Dr. Friedman interviewed the patients about their prior treatment experience elsewhere, all said they experienced excessive pain, only 33% received topical anesthesia, and none reported receiving an injectable anesthesia.

At the Dermatology and Laser Surgery Center, the protocol for corrective laser tattoo removal involves injectable anesthesia, Dr. Suggs said. They use a picosecond laser, a perfluorodecalin patch, and, if needed, nonablative fractional resurfacing at 1550 nm for scarring. The wavelength used for the picosecond laser (1064nm, 785nm or 532nm) is chosen based on patient characteristics and tattoo color or colors.

Lance Sitton Photography/Thinkstock

In a subset analysis, the investigators interviewed eight patients again after undergoing laser tattoo removal at their practice. All underwent treatment with a picosecond laser, perfluorodecalin patch, and injectable anesthesia. All reported minimal to no pain during the procedure and an optimal experience. No complications were noted.

Dr. Friedman and Dr. Suggs emphasized that consumers should be aware of the risks and potential for complications from laser tattoo removal. They recommend that all consumers – especially those at higher risk for complications such as higher Fitzpatrick skin type patients and those with multicolored tattoos – choose a provider with extensive training in the procedure, such as a board-certified dermatologist or plastic surgeon.

Dr. Suggs disclosed that she is an ambassador for Tri Sirena sun protective athletic apparel. Dr. Friedman disclosed that he is a member of the advisory board for Allergan, Solta Medical, Syneron-Candela, and Sienna Biopharmaceuticals. He is also a research investigator for Syneron-Candela and has received a research grant from Sienna.

[email protected]