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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Severe psoriasis linked to a higher risk for heart disease, study confirms
TOPLINE:
METHODOLOGY:
- Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
- In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
- The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
- The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.
TAKEAWAY:
- Of the 448 patients, 141 (31.5%) showed CMD.
- Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
- An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.
IN PRACTICE:
“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.
SOURCE:
Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.
LIMITATIONS:
A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.
DISCLOSURES:
The authors reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
- In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
- The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
- The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.
TAKEAWAY:
- Of the 448 patients, 141 (31.5%) showed CMD.
- Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
- An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.
IN PRACTICE:
“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.
SOURCE:
Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.
LIMITATIONS:
A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.
DISCLOSURES:
The authors reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
- In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
- The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
- The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.
TAKEAWAY:
- Of the 448 patients, 141 (31.5%) showed CMD.
- Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
- An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.
IN PRACTICE:
“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.
SOURCE:
Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.
LIMITATIONS:
A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.
DISCLOSURES:
The authors reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
European Commission grants approval of ritlecitinib for severe alopecia areata
This makes ritlecitinib the first medicine authorized by the EC to treat individuals with severe alopecia areata as young as 12 years of age.
Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. In June of 2023, the drug received FDA approval for the treatment of severe alopecia areata in people ages 12 and older in the United States.
According to a press release from Pfizer, which developed the drug, EC approval was based on the pivotal ALLEGRO clinical trial program, which included the ALLEGRO phase 2b/3 study that evaluated ritlecitinib in patients aged 12 years and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss). Results from this study showed that 13.4% of adults and adolescents achieved 90% or more scalp hair coverage (Severity of Alopecia Tool score of 10 or less) after 24 weeks of treatment with ritlecitinib 50 mg, compared with 1.5% of those on placebo.
The study also measured Patient Global Impression of Change (PGI-C). At week 24, 49.2% of participants treated with ritlecitinib reported a PGI-C response of “moderate” to “great” improvement in their alopecia areata, compared with 9.2% with placebo.
According to results from an ongoing, long-term phase 3 study of ritlecitinib known as ALLEGRO-LT, the most common adverse reactions reported from use of the drug included diarrhea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%), the company press release said.
This makes ritlecitinib the first medicine authorized by the EC to treat individuals with severe alopecia areata as young as 12 years of age.
Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. In June of 2023, the drug received FDA approval for the treatment of severe alopecia areata in people ages 12 and older in the United States.
According to a press release from Pfizer, which developed the drug, EC approval was based on the pivotal ALLEGRO clinical trial program, which included the ALLEGRO phase 2b/3 study that evaluated ritlecitinib in patients aged 12 years and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss). Results from this study showed that 13.4% of adults and adolescents achieved 90% or more scalp hair coverage (Severity of Alopecia Tool score of 10 or less) after 24 weeks of treatment with ritlecitinib 50 mg, compared with 1.5% of those on placebo.
The study also measured Patient Global Impression of Change (PGI-C). At week 24, 49.2% of participants treated with ritlecitinib reported a PGI-C response of “moderate” to “great” improvement in their alopecia areata, compared with 9.2% with placebo.
According to results from an ongoing, long-term phase 3 study of ritlecitinib known as ALLEGRO-LT, the most common adverse reactions reported from use of the drug included diarrhea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%), the company press release said.
This makes ritlecitinib the first medicine authorized by the EC to treat individuals with severe alopecia areata as young as 12 years of age.
Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. In June of 2023, the drug received FDA approval for the treatment of severe alopecia areata in people ages 12 and older in the United States.
According to a press release from Pfizer, which developed the drug, EC approval was based on the pivotal ALLEGRO clinical trial program, which included the ALLEGRO phase 2b/3 study that evaluated ritlecitinib in patients aged 12 years and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss). Results from this study showed that 13.4% of adults and adolescents achieved 90% or more scalp hair coverage (Severity of Alopecia Tool score of 10 or less) after 24 weeks of treatment with ritlecitinib 50 mg, compared with 1.5% of those on placebo.
The study also measured Patient Global Impression of Change (PGI-C). At week 24, 49.2% of participants treated with ritlecitinib reported a PGI-C response of “moderate” to “great” improvement in their alopecia areata, compared with 9.2% with placebo.
According to results from an ongoing, long-term phase 3 study of ritlecitinib known as ALLEGRO-LT, the most common adverse reactions reported from use of the drug included diarrhea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%), the company press release said.
Combining lasers: A recipe for maximizing results and patient satisfaction
SAN DIEGO –
“Using a fractional laser as a solo treatment is missing an opportunity to achieve more dramatic improvement for your patients,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said at the annual Masters of Aesthetics Symposium. Among the laser treatments he performs, “combination fractional treatments, typically using the 1927-nm laser” are associated with the highest patient satisfaction, he said.
The order of device use matters, he noted. First, he recommended, use a pulsed dye laser, KTP, or intense pulsed light (IPL) for erythema and telangiectasias, and/or a Q-switched or picosecond laser for pigment. Second, use an ablative or nonablative fractional laser for resurfacing. “A lot of seborrheic keratoses don’t respond to selective photothermolysis well, so I’ll use liquid nitrogen at the time of treatment and before or after treat with a picosecond laser,” added Dr. Avram. “This combined treatment approach is less painful than ablative fractional treatment. You’re going to have downtime anyway, so why not maximize the results at that one treatment session?”
The fractional 1927 laser delivers hundreds of thousands of microscopic pulses and fosters high water absorption, so it targets superficial skin conditions such as actinic keratoses, lentigines, and ephelides at depths of 200-250 microns. It thermally coagulates 30%-40% of skin, which heals without affecting surrounding skin and leaves no perceptible scar, he said.
Clinicians can also combine devices to treat scars. “For red scars, it’s often best to treat both erythema and scar texture with two lasers at the same session,” Dr. Avram said. Again, the order matters. First, he recommended using the pulse dye laser, IPL, or KTP at low fluence and short pulse duration. Second, treat with an ablative or nonablative fractional laser at a low density. “In my experience the ablative fractional lasers are far more efficacious,” he said. “Then we typically add a little Kenalog and 5-FU via laser-assisted drug delivery.”
Dr. Avram disclosed that he has received consulting fees from Allergan. He also reported holding shareholder interest and intellectual property rights with Cytrellis Biosystems.
SAN DIEGO –
“Using a fractional laser as a solo treatment is missing an opportunity to achieve more dramatic improvement for your patients,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said at the annual Masters of Aesthetics Symposium. Among the laser treatments he performs, “combination fractional treatments, typically using the 1927-nm laser” are associated with the highest patient satisfaction, he said.
The order of device use matters, he noted. First, he recommended, use a pulsed dye laser, KTP, or intense pulsed light (IPL) for erythema and telangiectasias, and/or a Q-switched or picosecond laser for pigment. Second, use an ablative or nonablative fractional laser for resurfacing. “A lot of seborrheic keratoses don’t respond to selective photothermolysis well, so I’ll use liquid nitrogen at the time of treatment and before or after treat with a picosecond laser,” added Dr. Avram. “This combined treatment approach is less painful than ablative fractional treatment. You’re going to have downtime anyway, so why not maximize the results at that one treatment session?”
The fractional 1927 laser delivers hundreds of thousands of microscopic pulses and fosters high water absorption, so it targets superficial skin conditions such as actinic keratoses, lentigines, and ephelides at depths of 200-250 microns. It thermally coagulates 30%-40% of skin, which heals without affecting surrounding skin and leaves no perceptible scar, he said.
Clinicians can also combine devices to treat scars. “For red scars, it’s often best to treat both erythema and scar texture with two lasers at the same session,” Dr. Avram said. Again, the order matters. First, he recommended using the pulse dye laser, IPL, or KTP at low fluence and short pulse duration. Second, treat with an ablative or nonablative fractional laser at a low density. “In my experience the ablative fractional lasers are far more efficacious,” he said. “Then we typically add a little Kenalog and 5-FU via laser-assisted drug delivery.”
Dr. Avram disclosed that he has received consulting fees from Allergan. He also reported holding shareholder interest and intellectual property rights with Cytrellis Biosystems.
SAN DIEGO –
“Using a fractional laser as a solo treatment is missing an opportunity to achieve more dramatic improvement for your patients,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said at the annual Masters of Aesthetics Symposium. Among the laser treatments he performs, “combination fractional treatments, typically using the 1927-nm laser” are associated with the highest patient satisfaction, he said.
The order of device use matters, he noted. First, he recommended, use a pulsed dye laser, KTP, or intense pulsed light (IPL) for erythema and telangiectasias, and/or a Q-switched or picosecond laser for pigment. Second, use an ablative or nonablative fractional laser for resurfacing. “A lot of seborrheic keratoses don’t respond to selective photothermolysis well, so I’ll use liquid nitrogen at the time of treatment and before or after treat with a picosecond laser,” added Dr. Avram. “This combined treatment approach is less painful than ablative fractional treatment. You’re going to have downtime anyway, so why not maximize the results at that one treatment session?”
The fractional 1927 laser delivers hundreds of thousands of microscopic pulses and fosters high water absorption, so it targets superficial skin conditions such as actinic keratoses, lentigines, and ephelides at depths of 200-250 microns. It thermally coagulates 30%-40% of skin, which heals without affecting surrounding skin and leaves no perceptible scar, he said.
Clinicians can also combine devices to treat scars. “For red scars, it’s often best to treat both erythema and scar texture with two lasers at the same session,” Dr. Avram said. Again, the order matters. First, he recommended using the pulse dye laser, IPL, or KTP at low fluence and short pulse duration. Second, treat with an ablative or nonablative fractional laser at a low density. “In my experience the ablative fractional lasers are far more efficacious,” he said. “Then we typically add a little Kenalog and 5-FU via laser-assisted drug delivery.”
Dr. Avram disclosed that he has received consulting fees from Allergan. He also reported holding shareholder interest and intellectual property rights with Cytrellis Biosystems.
AT MOAS 2023
When treating scars, ‘rehabilitation’ is the goal, not perfection
SAN DIEGO – , according to Victor Ross, MD.
“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.
“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”
Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.
In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”
He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.
New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.
Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.
SAN DIEGO – , according to Victor Ross, MD.
“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.
“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”
Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.
In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”
He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.
New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.
Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.
SAN DIEGO – , according to Victor Ross, MD.
“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.
“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”
Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.
In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”
He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.
New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.
Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.
FROM MOAS 2023
CHMP recommends marketing of biologic for atopic dermatitis
The
who are candidates for systemic therapy.Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.
According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.
Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
The
who are candidates for systemic therapy.Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.
According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.
Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
The
who are candidates for systemic therapy.Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.
According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.
Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
Hyperbaric oxygen therapy beneficial for calciphylaxis?
, report Daniela Kroshinsky, MD, MPH, of the department of dermatology at Massachusetts General Hospital, Boston, and colleagues.
Although intravenous sodium thiosulfate (IV STS) is considered standard care in the treatment of calciphylaxis, HBOT has been reported to have beneficial effects, they noted.
In their study, the researchers retrospectively reviewed records of 93 patients newly diagnosed with calciphylaxis, seen at Massachusetts General Hospital, between January 2006 and December 2021. They compared mortality and wound healing outcomes for 57 patients treated with IV STS only (control group) with those of 36 patients treated with HBOT plus IV STS (treatment group). Traditional survival analyses and Cox proportional hazard modeling were used to examine mortality data, and mixed effects modeling was used to analyze longitudinal wound outcomes. The study was published in the Journal of the American Academy of Dermatology.
Univariate survival analyses showed that HBOT plus IV STS was associated with significantly longer survival time than IV STS alone (P = .016), particularly for those with nonnephrogenic calciphylaxis (P < .0001), they report. An increased number of HBOT sessions conferred improved mortality outcomes, with 1, 5, 10, and 20 sessions yielding decreasing hazard ratios.
There was also a significant positive association between an increasing number of HBOT sessions and increased wound score (P = .042). Increases were seen with each session.
Anxiety/claustrophobia was the most common side effect reported among those in the HBOT group (22%).
“Given the proposed benefits and seemingly low side effect profile, it is the authors’ recommendation that HBOT be offered as an additional intervention to patients with calciphylaxis, especially if they have open wounds, to improve outcomes and expedite wound healing,” the researchers concluded.
Limitations, they noted, included the small sample size, retrospective design, and the potential for not adequately capturing patients who received external care. They were also unable to match patients by disease or wound severity. Large prospective trials would help clarify the role of HBOT for calciphylaxis, they added.
The researchers reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
, report Daniela Kroshinsky, MD, MPH, of the department of dermatology at Massachusetts General Hospital, Boston, and colleagues.
Although intravenous sodium thiosulfate (IV STS) is considered standard care in the treatment of calciphylaxis, HBOT has been reported to have beneficial effects, they noted.
In their study, the researchers retrospectively reviewed records of 93 patients newly diagnosed with calciphylaxis, seen at Massachusetts General Hospital, between January 2006 and December 2021. They compared mortality and wound healing outcomes for 57 patients treated with IV STS only (control group) with those of 36 patients treated with HBOT plus IV STS (treatment group). Traditional survival analyses and Cox proportional hazard modeling were used to examine mortality data, and mixed effects modeling was used to analyze longitudinal wound outcomes. The study was published in the Journal of the American Academy of Dermatology.
Univariate survival analyses showed that HBOT plus IV STS was associated with significantly longer survival time than IV STS alone (P = .016), particularly for those with nonnephrogenic calciphylaxis (P < .0001), they report. An increased number of HBOT sessions conferred improved mortality outcomes, with 1, 5, 10, and 20 sessions yielding decreasing hazard ratios.
There was also a significant positive association between an increasing number of HBOT sessions and increased wound score (P = .042). Increases were seen with each session.
Anxiety/claustrophobia was the most common side effect reported among those in the HBOT group (22%).
“Given the proposed benefits and seemingly low side effect profile, it is the authors’ recommendation that HBOT be offered as an additional intervention to patients with calciphylaxis, especially if they have open wounds, to improve outcomes and expedite wound healing,” the researchers concluded.
Limitations, they noted, included the small sample size, retrospective design, and the potential for not adequately capturing patients who received external care. They were also unable to match patients by disease or wound severity. Large prospective trials would help clarify the role of HBOT for calciphylaxis, they added.
The researchers reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
, report Daniela Kroshinsky, MD, MPH, of the department of dermatology at Massachusetts General Hospital, Boston, and colleagues.
Although intravenous sodium thiosulfate (IV STS) is considered standard care in the treatment of calciphylaxis, HBOT has been reported to have beneficial effects, they noted.
In their study, the researchers retrospectively reviewed records of 93 patients newly diagnosed with calciphylaxis, seen at Massachusetts General Hospital, between January 2006 and December 2021. They compared mortality and wound healing outcomes for 57 patients treated with IV STS only (control group) with those of 36 patients treated with HBOT plus IV STS (treatment group). Traditional survival analyses and Cox proportional hazard modeling were used to examine mortality data, and mixed effects modeling was used to analyze longitudinal wound outcomes. The study was published in the Journal of the American Academy of Dermatology.
Univariate survival analyses showed that HBOT plus IV STS was associated with significantly longer survival time than IV STS alone (P = .016), particularly for those with nonnephrogenic calciphylaxis (P < .0001), they report. An increased number of HBOT sessions conferred improved mortality outcomes, with 1, 5, 10, and 20 sessions yielding decreasing hazard ratios.
There was also a significant positive association between an increasing number of HBOT sessions and increased wound score (P = .042). Increases were seen with each session.
Anxiety/claustrophobia was the most common side effect reported among those in the HBOT group (22%).
“Given the proposed benefits and seemingly low side effect profile, it is the authors’ recommendation that HBOT be offered as an additional intervention to patients with calciphylaxis, especially if they have open wounds, to improve outcomes and expedite wound healing,” the researchers concluded.
Limitations, they noted, included the small sample size, retrospective design, and the potential for not adequately capturing patients who received external care. They were also unable to match patients by disease or wound severity. Large prospective trials would help clarify the role of HBOT for calciphylaxis, they added.
The researchers reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Company submits supplemental NDA for topical atopic dermatitis treatment
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
Skin has different daytime and nighttime needs, emerging circadian research suggests
SAN DIEGO –
“Paying attention to the circadian rhythm of the skin is every bit as important as moisturizing the skin,” Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “It is paramount to both your morning and evening skin regimen routine,” she added.
Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. “These natural processes respond primarily to light and dark and affect most living things, including animals, plants, and microbes,” she said. “The circadian system is composed of peripheral circadian oscillators in many other cells, including the skin.”
The science has been around awhile, but dermatologists didn’t understand its impact until recently, she said.
In 1729, the French astronomer Jean-Jacques d’Ortous de Mairan demonstrated that mimosa leaves, which open at dawn and close at dusk, continued this cycle even when kept in darkness. In the 1970s, Seymour Benzer and Ronald Konopka showed that mutations in an unknown gene disrupted the circadian clock of fruit flies.
And in 2017, the Nobel Prize in Physiology or Medicine was awarded to Jeffrey C. Hall, Michael Rosbash, and Michael W. Young for discovering molecular mechanisms that control circadian rhythm. Using fruit flies as a model, they isolated a gene that controls the normal daily biological rhythm.
“They showed that this gene encodes a protein that accumulates in the cell during the night and is then degraded during the day, and they identified additional protein components, exposing the mechanism governing the self-sustaining clockwork inside the cell,” said Dr. Shamban.
In humans and other mammals, the primary body clock is located in the suprachiasmatic nucleus, a cluster of approximately 10,000 neurons located on either side of the midline above the optic chiasma, about 3 cm behind the eyes. Several clock genes have been identified that regulate and control transcription and translation.
“Expression of these core clock genes inside the cell influences many signaling pathways, which allows the cells to identify the time of day and perform their appropriate function,” Dr. Shamban said. “Furthermore, phosphorylation of core clock proteins leads to degradation to keep the 24-hour cycle in sync.”
Photoreceptive molecules known as opsins also appear to play a role in regulating the skin’s clock. A systematic review of 22 articles published in 2020 found that opsins are present in keratinocytes, melanocytes, dermal fibroblasts, and hair follicle cells, and they have been shown to mediate wound healing, melanogenesis, hair growth, and skin photoaging in human and nonhuman species.
“You may wonder, why does the skin respond so nicely to light?” Dr. Shamban said. “Because it contains opsins, and light exposure through opsin-regulated pathways stimulates melanin production.”
Patients can support their skin’s clock genes by understanding that skin barrier functions such as photoprotection and sebum production are increased during the day, while skin permeability processes such as DNA repair, cell proliferation, and blood flow are enhanced at night.
“Your skin has different daytime and nighttime needs,” Dr. Shamban commented. “Simply put, daytime is defense, and nighttime is offense. I think we’ve known this intuitively, but to know that there is science supporting this idea is important.”
Dr. Shamban wrote the book “Heal Your Skin: The Breakthrough Plan for Renewal” (Wiley, 2011). She disclosed that she conducts clinical trials for many pharmaceutical and device companies.
SAN DIEGO –
“Paying attention to the circadian rhythm of the skin is every bit as important as moisturizing the skin,” Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “It is paramount to both your morning and evening skin regimen routine,” she added.
Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. “These natural processes respond primarily to light and dark and affect most living things, including animals, plants, and microbes,” she said. “The circadian system is composed of peripheral circadian oscillators in many other cells, including the skin.”
The science has been around awhile, but dermatologists didn’t understand its impact until recently, she said.
In 1729, the French astronomer Jean-Jacques d’Ortous de Mairan demonstrated that mimosa leaves, which open at dawn and close at dusk, continued this cycle even when kept in darkness. In the 1970s, Seymour Benzer and Ronald Konopka showed that mutations in an unknown gene disrupted the circadian clock of fruit flies.
And in 2017, the Nobel Prize in Physiology or Medicine was awarded to Jeffrey C. Hall, Michael Rosbash, and Michael W. Young for discovering molecular mechanisms that control circadian rhythm. Using fruit flies as a model, they isolated a gene that controls the normal daily biological rhythm.
“They showed that this gene encodes a protein that accumulates in the cell during the night and is then degraded during the day, and they identified additional protein components, exposing the mechanism governing the self-sustaining clockwork inside the cell,” said Dr. Shamban.
In humans and other mammals, the primary body clock is located in the suprachiasmatic nucleus, a cluster of approximately 10,000 neurons located on either side of the midline above the optic chiasma, about 3 cm behind the eyes. Several clock genes have been identified that regulate and control transcription and translation.
“Expression of these core clock genes inside the cell influences many signaling pathways, which allows the cells to identify the time of day and perform their appropriate function,” Dr. Shamban said. “Furthermore, phosphorylation of core clock proteins leads to degradation to keep the 24-hour cycle in sync.”
Photoreceptive molecules known as opsins also appear to play a role in regulating the skin’s clock. A systematic review of 22 articles published in 2020 found that opsins are present in keratinocytes, melanocytes, dermal fibroblasts, and hair follicle cells, and they have been shown to mediate wound healing, melanogenesis, hair growth, and skin photoaging in human and nonhuman species.
“You may wonder, why does the skin respond so nicely to light?” Dr. Shamban said. “Because it contains opsins, and light exposure through opsin-regulated pathways stimulates melanin production.”
Patients can support their skin’s clock genes by understanding that skin barrier functions such as photoprotection and sebum production are increased during the day, while skin permeability processes such as DNA repair, cell proliferation, and blood flow are enhanced at night.
“Your skin has different daytime and nighttime needs,” Dr. Shamban commented. “Simply put, daytime is defense, and nighttime is offense. I think we’ve known this intuitively, but to know that there is science supporting this idea is important.”
Dr. Shamban wrote the book “Heal Your Skin: The Breakthrough Plan for Renewal” (Wiley, 2011). She disclosed that she conducts clinical trials for many pharmaceutical and device companies.
SAN DIEGO –
“Paying attention to the circadian rhythm of the skin is every bit as important as moisturizing the skin,” Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “It is paramount to both your morning and evening skin regimen routine,” she added.
Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. “These natural processes respond primarily to light and dark and affect most living things, including animals, plants, and microbes,” she said. “The circadian system is composed of peripheral circadian oscillators in many other cells, including the skin.”
The science has been around awhile, but dermatologists didn’t understand its impact until recently, she said.
In 1729, the French astronomer Jean-Jacques d’Ortous de Mairan demonstrated that mimosa leaves, which open at dawn and close at dusk, continued this cycle even when kept in darkness. In the 1970s, Seymour Benzer and Ronald Konopka showed that mutations in an unknown gene disrupted the circadian clock of fruit flies.
And in 2017, the Nobel Prize in Physiology or Medicine was awarded to Jeffrey C. Hall, Michael Rosbash, and Michael W. Young for discovering molecular mechanisms that control circadian rhythm. Using fruit flies as a model, they isolated a gene that controls the normal daily biological rhythm.
“They showed that this gene encodes a protein that accumulates in the cell during the night and is then degraded during the day, and they identified additional protein components, exposing the mechanism governing the self-sustaining clockwork inside the cell,” said Dr. Shamban.
In humans and other mammals, the primary body clock is located in the suprachiasmatic nucleus, a cluster of approximately 10,000 neurons located on either side of the midline above the optic chiasma, about 3 cm behind the eyes. Several clock genes have been identified that regulate and control transcription and translation.
“Expression of these core clock genes inside the cell influences many signaling pathways, which allows the cells to identify the time of day and perform their appropriate function,” Dr. Shamban said. “Furthermore, phosphorylation of core clock proteins leads to degradation to keep the 24-hour cycle in sync.”
Photoreceptive molecules known as opsins also appear to play a role in regulating the skin’s clock. A systematic review of 22 articles published in 2020 found that opsins are present in keratinocytes, melanocytes, dermal fibroblasts, and hair follicle cells, and they have been shown to mediate wound healing, melanogenesis, hair growth, and skin photoaging in human and nonhuman species.
“You may wonder, why does the skin respond so nicely to light?” Dr. Shamban said. “Because it contains opsins, and light exposure through opsin-regulated pathways stimulates melanin production.”
Patients can support their skin’s clock genes by understanding that skin barrier functions such as photoprotection and sebum production are increased during the day, while skin permeability processes such as DNA repair, cell proliferation, and blood flow are enhanced at night.
“Your skin has different daytime and nighttime needs,” Dr. Shamban commented. “Simply put, daytime is defense, and nighttime is offense. I think we’ve known this intuitively, but to know that there is science supporting this idea is important.”
Dr. Shamban wrote the book “Heal Your Skin: The Breakthrough Plan for Renewal” (Wiley, 2011). She disclosed that she conducts clinical trials for many pharmaceutical and device companies.
AT MOAS 2023
CoolSculpting remains most popular procedure for noninvasive fat removal, expert says
SAN DIEGO – , some aesthetic experts wondered how consumers would embrace the fat reduction procedure going forward.
The negative publicity surrounding this case “is thought to have detracted from some of the volume of it [in terms of demand], but it looks like it’s coming back again,” Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, said during a presentation on noninvasive fat removal treatment options at the annual Masters of Aesthetics Symposium.
In fact, he said, CoolSculpting accounts for an estimated 72% of noninvasive fat removal treatments performed in the United States. “By and large, there is high satisfaction with this procedure,” said Dr. Ibrahimi. “There have been about 17 million procedures done worldwide. Paradoxical adipose hyperplasia is a very rare side effect. As newer iterations of this technology have come out, I think there is an even lower incidence.”
CoolSculpting, or cryolipolysis, freezes excess fat to remove it from stubborn areas via panniculitis. The technology was developed by Dieter Manstein MD, PhD, and R. Rox Anderson, MD, at Massachusetts General Hospital and Harvard Medical School, both in Boston, and cleared by the U.S. Food and Drug Administration for noninvasive fat removal in 2010.
“If you kill a fat cell in an adult, it can’t come back,” Dr. Ibrahimi said. “When this technology first came out it was very simple. We treated an area once and were done. Now we know to treat the area multiple times, and you can treat a much larger volume in a patient during one session safely. You can bring about dramatic results, but it often takes a series of 35-minute treatment cycles and about 3 months to see clinical results. There are published studies showing that results are persisting even 10 years after treatment. This is nice, because I tell my patients, ‘if you keep up with your diet and exercise, we don’t expect the fat to come back.’ ”
Other noninvasive options for fat removal include the following:
- Ultrasound. Options include high-intensity focused ultrasound (Liposonix) and pulsed focused ultrasound (UltraShape). Dr. Ibrahimi described these devices as “very painful, and the results were very difficult to reproduce from the initial clinical studies.”
- Low-level light therapy. Early devices on the market include Zerona and UltraSlim. “Oftentimes these lacked any sort of histological analysis,” he said. “There was no obvious mechanism of action, and questionable efficacy.”
- Laser. Powered by a 1060-nm laser, SculpSure can reduce fat cells safely in 25-minute treatment sessions, Dr. Ibrahimi said. Each session is delivered with one of four available applicators and involves 4 minutes of heating and the next 21 minutes alternating between heating and cooling. “You’re trying to reach a target temperature that kills fat cells,” he explained. “The beauty of having these applicators is that you can kind of customize to the individual patient; it uses contact cooling, and it’s safe for all Fitzpatrick skin types. This device results in a 10%-12% reduction in fat, so it’s clinically significant but very modest.”
A robotic version of the technology, known as the Robotic Fat Killer, is also available. So is the EON, a touchless 1064-nm laser FDA cleared for abdominal, flank, thigh, and back fat reduction. “It adapts to the body shape of the area and individual to deliver a customized treatment,” Dr. Ibrahimi said.
- Radiofrequency. Most devices on the market, such as truSculpt and Vanquish, are powered by monopolar radiofrequency (RF) energy. “Similar to the 1060-nm laser, you can customize these treatments,” he said. “You’re treating to a target temperature. It involves 15-minute cycles, and there are clinical, histology, and ultrasound data supporting this technology.”
Dr. Ibrahimi uses truSculpt and CoolSculpting in his practice, “but sometimes you have patients who are ‘too fit’ for CoolSculpting; they don’t fit the handpiece perfectly,” he said. “That’s where having a monopolar RF or a 1060-nm laser is useful, to help you hone in on those stubborn pockets of fat.”
- Deoxycholic acid. While not a device, deoxycholic acid (Kybella), administered subcutaneously, is approved by the FDA for improving “the appearance of moderate to severe convexity or fullness associated with submental fat” in adults. “A lot of people use it off-label on the abdomen and other stubborn areas,” Dr. Ibrahimi said. “It often requires a series of treatments. That’s the biggest limiting issue with using this technology. It works well, but compared to CoolSculpting, there is a lot of swelling and bruising, which you would expect with an injectable. Managing that down time and hand holding is difficult. But if you can get patients to buy into the downtime, [it yields] pretty impressive results.”
Dr. Ibrahimi also discussed the promise of electrical muscle stimulation for strengthening, firming, and toning muscles. The technology applies an electrical current through electrodes placed on the skin, which stimulates muscles, or through an electromagnetic field.
In a published study of 45 men and women, Dr. Ibrahimi, Anne Chapas, MD, medical director of UnionDerm in New York, and colleagues evaluated the safety and efficacy of an electrical muscle stimulation system for improving muscle strength and toning of the upper extremities.
For the treatments, they used disposable contact pads to place pairs of electrodes on the biceps and on the triceps. All patients (median age 42) received 30-minute treatments twice weekly for 2 or 3 weeks, corresponding to four or six total sessions respectively, depending on the study site. Follow-ups were conducted 30 and 90 days after treatment. They used a validated dynamometer device to measure strength at baseline, at the final treatment session, and at the post-treatment 30- and 90-day visits.
“We saw about a 40% increase in strength in the biceps and about a 30% increase in strength in the triceps,” Dr. Ibrahimi said. “Interestingly, the effect got greater at 30 and 90 days, so this is something that lingers on for quite a while.” In addition to the increase in strength, the researchers and patients noted an improvement in the appearance of the arms. He predicted that this technology “is going to play a role in functional medicine and getting injured athletes back to their sports faster.”
Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera (manufacturer of truSculpt), Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies (none are relevant to the treatments mentioned in this story).
SAN DIEGO – , some aesthetic experts wondered how consumers would embrace the fat reduction procedure going forward.
The negative publicity surrounding this case “is thought to have detracted from some of the volume of it [in terms of demand], but it looks like it’s coming back again,” Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, said during a presentation on noninvasive fat removal treatment options at the annual Masters of Aesthetics Symposium.
In fact, he said, CoolSculpting accounts for an estimated 72% of noninvasive fat removal treatments performed in the United States. “By and large, there is high satisfaction with this procedure,” said Dr. Ibrahimi. “There have been about 17 million procedures done worldwide. Paradoxical adipose hyperplasia is a very rare side effect. As newer iterations of this technology have come out, I think there is an even lower incidence.”
CoolSculpting, or cryolipolysis, freezes excess fat to remove it from stubborn areas via panniculitis. The technology was developed by Dieter Manstein MD, PhD, and R. Rox Anderson, MD, at Massachusetts General Hospital and Harvard Medical School, both in Boston, and cleared by the U.S. Food and Drug Administration for noninvasive fat removal in 2010.
“If you kill a fat cell in an adult, it can’t come back,” Dr. Ibrahimi said. “When this technology first came out it was very simple. We treated an area once and were done. Now we know to treat the area multiple times, and you can treat a much larger volume in a patient during one session safely. You can bring about dramatic results, but it often takes a series of 35-minute treatment cycles and about 3 months to see clinical results. There are published studies showing that results are persisting even 10 years after treatment. This is nice, because I tell my patients, ‘if you keep up with your diet and exercise, we don’t expect the fat to come back.’ ”
Other noninvasive options for fat removal include the following:
- Ultrasound. Options include high-intensity focused ultrasound (Liposonix) and pulsed focused ultrasound (UltraShape). Dr. Ibrahimi described these devices as “very painful, and the results were very difficult to reproduce from the initial clinical studies.”
- Low-level light therapy. Early devices on the market include Zerona and UltraSlim. “Oftentimes these lacked any sort of histological analysis,” he said. “There was no obvious mechanism of action, and questionable efficacy.”
- Laser. Powered by a 1060-nm laser, SculpSure can reduce fat cells safely in 25-minute treatment sessions, Dr. Ibrahimi said. Each session is delivered with one of four available applicators and involves 4 minutes of heating and the next 21 minutes alternating between heating and cooling. “You’re trying to reach a target temperature that kills fat cells,” he explained. “The beauty of having these applicators is that you can kind of customize to the individual patient; it uses contact cooling, and it’s safe for all Fitzpatrick skin types. This device results in a 10%-12% reduction in fat, so it’s clinically significant but very modest.”
A robotic version of the technology, known as the Robotic Fat Killer, is also available. So is the EON, a touchless 1064-nm laser FDA cleared for abdominal, flank, thigh, and back fat reduction. “It adapts to the body shape of the area and individual to deliver a customized treatment,” Dr. Ibrahimi said.
- Radiofrequency. Most devices on the market, such as truSculpt and Vanquish, are powered by monopolar radiofrequency (RF) energy. “Similar to the 1060-nm laser, you can customize these treatments,” he said. “You’re treating to a target temperature. It involves 15-minute cycles, and there are clinical, histology, and ultrasound data supporting this technology.”
Dr. Ibrahimi uses truSculpt and CoolSculpting in his practice, “but sometimes you have patients who are ‘too fit’ for CoolSculpting; they don’t fit the handpiece perfectly,” he said. “That’s where having a monopolar RF or a 1060-nm laser is useful, to help you hone in on those stubborn pockets of fat.”
- Deoxycholic acid. While not a device, deoxycholic acid (Kybella), administered subcutaneously, is approved by the FDA for improving “the appearance of moderate to severe convexity or fullness associated with submental fat” in adults. “A lot of people use it off-label on the abdomen and other stubborn areas,” Dr. Ibrahimi said. “It often requires a series of treatments. That’s the biggest limiting issue with using this technology. It works well, but compared to CoolSculpting, there is a lot of swelling and bruising, which you would expect with an injectable. Managing that down time and hand holding is difficult. But if you can get patients to buy into the downtime, [it yields] pretty impressive results.”
Dr. Ibrahimi also discussed the promise of electrical muscle stimulation for strengthening, firming, and toning muscles. The technology applies an electrical current through electrodes placed on the skin, which stimulates muscles, or through an electromagnetic field.
In a published study of 45 men and women, Dr. Ibrahimi, Anne Chapas, MD, medical director of UnionDerm in New York, and colleagues evaluated the safety and efficacy of an electrical muscle stimulation system for improving muscle strength and toning of the upper extremities.
For the treatments, they used disposable contact pads to place pairs of electrodes on the biceps and on the triceps. All patients (median age 42) received 30-minute treatments twice weekly for 2 or 3 weeks, corresponding to four or six total sessions respectively, depending on the study site. Follow-ups were conducted 30 and 90 days after treatment. They used a validated dynamometer device to measure strength at baseline, at the final treatment session, and at the post-treatment 30- and 90-day visits.
“We saw about a 40% increase in strength in the biceps and about a 30% increase in strength in the triceps,” Dr. Ibrahimi said. “Interestingly, the effect got greater at 30 and 90 days, so this is something that lingers on for quite a while.” In addition to the increase in strength, the researchers and patients noted an improvement in the appearance of the arms. He predicted that this technology “is going to play a role in functional medicine and getting injured athletes back to their sports faster.”
Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera (manufacturer of truSculpt), Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies (none are relevant to the treatments mentioned in this story).
SAN DIEGO – , some aesthetic experts wondered how consumers would embrace the fat reduction procedure going forward.
The negative publicity surrounding this case “is thought to have detracted from some of the volume of it [in terms of demand], but it looks like it’s coming back again,” Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, said during a presentation on noninvasive fat removal treatment options at the annual Masters of Aesthetics Symposium.
In fact, he said, CoolSculpting accounts for an estimated 72% of noninvasive fat removal treatments performed in the United States. “By and large, there is high satisfaction with this procedure,” said Dr. Ibrahimi. “There have been about 17 million procedures done worldwide. Paradoxical adipose hyperplasia is a very rare side effect. As newer iterations of this technology have come out, I think there is an even lower incidence.”
CoolSculpting, or cryolipolysis, freezes excess fat to remove it from stubborn areas via panniculitis. The technology was developed by Dieter Manstein MD, PhD, and R. Rox Anderson, MD, at Massachusetts General Hospital and Harvard Medical School, both in Boston, and cleared by the U.S. Food and Drug Administration for noninvasive fat removal in 2010.
“If you kill a fat cell in an adult, it can’t come back,” Dr. Ibrahimi said. “When this technology first came out it was very simple. We treated an area once and were done. Now we know to treat the area multiple times, and you can treat a much larger volume in a patient during one session safely. You can bring about dramatic results, but it often takes a series of 35-minute treatment cycles and about 3 months to see clinical results. There are published studies showing that results are persisting even 10 years after treatment. This is nice, because I tell my patients, ‘if you keep up with your diet and exercise, we don’t expect the fat to come back.’ ”
Other noninvasive options for fat removal include the following:
- Ultrasound. Options include high-intensity focused ultrasound (Liposonix) and pulsed focused ultrasound (UltraShape). Dr. Ibrahimi described these devices as “very painful, and the results were very difficult to reproduce from the initial clinical studies.”
- Low-level light therapy. Early devices on the market include Zerona and UltraSlim. “Oftentimes these lacked any sort of histological analysis,” he said. “There was no obvious mechanism of action, and questionable efficacy.”
- Laser. Powered by a 1060-nm laser, SculpSure can reduce fat cells safely in 25-minute treatment sessions, Dr. Ibrahimi said. Each session is delivered with one of four available applicators and involves 4 minutes of heating and the next 21 minutes alternating between heating and cooling. “You’re trying to reach a target temperature that kills fat cells,” he explained. “The beauty of having these applicators is that you can kind of customize to the individual patient; it uses contact cooling, and it’s safe for all Fitzpatrick skin types. This device results in a 10%-12% reduction in fat, so it’s clinically significant but very modest.”
A robotic version of the technology, known as the Robotic Fat Killer, is also available. So is the EON, a touchless 1064-nm laser FDA cleared for abdominal, flank, thigh, and back fat reduction. “It adapts to the body shape of the area and individual to deliver a customized treatment,” Dr. Ibrahimi said.
- Radiofrequency. Most devices on the market, such as truSculpt and Vanquish, are powered by monopolar radiofrequency (RF) energy. “Similar to the 1060-nm laser, you can customize these treatments,” he said. “You’re treating to a target temperature. It involves 15-minute cycles, and there are clinical, histology, and ultrasound data supporting this technology.”
Dr. Ibrahimi uses truSculpt and CoolSculpting in his practice, “but sometimes you have patients who are ‘too fit’ for CoolSculpting; they don’t fit the handpiece perfectly,” he said. “That’s where having a monopolar RF or a 1060-nm laser is useful, to help you hone in on those stubborn pockets of fat.”
- Deoxycholic acid. While not a device, deoxycholic acid (Kybella), administered subcutaneously, is approved by the FDA for improving “the appearance of moderate to severe convexity or fullness associated with submental fat” in adults. “A lot of people use it off-label on the abdomen and other stubborn areas,” Dr. Ibrahimi said. “It often requires a series of treatments. That’s the biggest limiting issue with using this technology. It works well, but compared to CoolSculpting, there is a lot of swelling and bruising, which you would expect with an injectable. Managing that down time and hand holding is difficult. But if you can get patients to buy into the downtime, [it yields] pretty impressive results.”
Dr. Ibrahimi also discussed the promise of electrical muscle stimulation for strengthening, firming, and toning muscles. The technology applies an electrical current through electrodes placed on the skin, which stimulates muscles, or through an electromagnetic field.
In a published study of 45 men and women, Dr. Ibrahimi, Anne Chapas, MD, medical director of UnionDerm in New York, and colleagues evaluated the safety and efficacy of an electrical muscle stimulation system for improving muscle strength and toning of the upper extremities.
For the treatments, they used disposable contact pads to place pairs of electrodes on the biceps and on the triceps. All patients (median age 42) received 30-minute treatments twice weekly for 2 or 3 weeks, corresponding to four or six total sessions respectively, depending on the study site. Follow-ups were conducted 30 and 90 days after treatment. They used a validated dynamometer device to measure strength at baseline, at the final treatment session, and at the post-treatment 30- and 90-day visits.
“We saw about a 40% increase in strength in the biceps and about a 30% increase in strength in the triceps,” Dr. Ibrahimi said. “Interestingly, the effect got greater at 30 and 90 days, so this is something that lingers on for quite a while.” In addition to the increase in strength, the researchers and patients noted an improvement in the appearance of the arms. He predicted that this technology “is going to play a role in functional medicine and getting injured athletes back to their sports faster.”
Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera (manufacturer of truSculpt), Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies (none are relevant to the treatments mentioned in this story).
Going into solo practice? An expert shares tips
SAN DIEGO – When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?
She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.
The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”
On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:
Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”
Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”
Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”
Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”
Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.
Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.
Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”
Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.
Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.
Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.
Find an accountant. That person can help set up a bookkeeping process.
What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”
Dr. DiGiorgio reported having no relevant disclosures.
SAN DIEGO – When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?
She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.
The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”
On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:
Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”
Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”
Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”
Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”
Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.
Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.
Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”
Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.
Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.
Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.
Find an accountant. That person can help set up a bookkeeping process.
What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”
Dr. DiGiorgio reported having no relevant disclosures.
SAN DIEGO – When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?
She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.
The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”
On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:
Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”
Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”
Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”
Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”
Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.
Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.
Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”
Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.
Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.
Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.
Find an accountant. That person can help set up a bookkeeping process.
What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”
Dr. DiGiorgio reported having no relevant disclosures.
AT MOAS 2023