Sebacia, a privately held, commercial-stage dermatology and aesthetics company, announced new results from its real-world study in Europe evaluating Sebacia Microparticles for treatment of acne. The study demonstrated an average 85 percent improvement in facial acne at 12 months.
Sebacia Microparticles were cleared in 2018 by the U.S. Food and Drug Administration (FDA) for use as an accessory to 1,064nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild-to-moderate inflammatory acne vulgaris.
Jill S. Waibel, MD, founder of the Miami Dermatology and Laser Institute and a Sebacia U.S. clinical trial investigator, and Arielle N.B. Kauvar, MD, a dermatologist practicing at New York Laser & Skin Care, presented the results at the American Academy of Dermatology (AAD) 2019 Annual Meeting.
In Sebacia's EU registry study, patients were prescribed a two-to-four week course of topical retinoid + benzoyl peroxide (BPO) followed by three weekly in-office treatments of Sebacia Microparticles. Patients stopped the retinoid + BPO after treatment, and physicians were directed to manage patients to clinical success, including reintroducing acne medications if desired. The ongoing registry study, which is being conducted at nine non-academic clinical practices in Europe and to date has enrolled 76 patients, demonstrated a clinically significant effect of the combination treatment on long-term acne outcomes and acne medication usage.
Key results to date include:
- At 12 months, the mean acne inflammatory lesion count (ILC) improvement was 85 percent from baseline and 56 percent of patients were free of acne medications.
- At 6 months, the mean ILC improvement was 74 percent from baseline, with 70 pecent of patients free of acne medications.
- 67 percent of patients had an Investigator Global assessment (IGA) score of clear or almost clear at 12 months, an improvement from 63 percent of patients at 6 months.
- Only 8 percent and 14 percent of patients were prescribed systemic acne medications at 6 and 12 months respectively.
“These data demonstrate the robust, long-term clinical effectiveness of Sebacia Microparticles in acne patients out to a year, supporting the addition of this important topical and localized treatment to our poly-therapeutic approach to managing acne,” said Dr. Waibel. “Sebacia Microparticles represent an innovative new in-office treatment for patients with mild-to-moderate acne, especially as it may help avoid progression to second- and third-line treatments, including systemic acne medications.”
“We are very pleased with the results of our European real-world study as it will help dermatologists understand how Sebacia Microparticles can be integrated into their treatment algorithm for treating acne,” said Anthony Lando, CEO of Sebacia. “We look forward to engaging with the dermatology community and making Sebacia Microparticles available to U.S. physicians via our commercial launch in mid-2019.”
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