DULUTH, Ga., Oct. 25, 2019 /PRNewswire/ -- Sebacia, Inc., a privately held, commercial stage dermatology and aesthetics company, today announced new positive real-world results from its two registry studies evaluating the Company's proprietary Sebacia Microparticles in Europe and the U.S. The results were presented at the American Society for Dermatologic Surgery (ASDS) 2019 Annual Meeting in two oral presentations.
The ongoing EU real-world registry study was designed to evaluate acne outcomes in patients that received pre-treatment with common first-line topical acne medications prior to the Sebacia treatment. Patients were prescribed a 2-4-week course of topical retinoid followed by three weekly in-office treatments of Sebacia Microparticles at commercial centers. The study is being conducted at nine non-academic clinical practices in Europe and to date has enrolled 76 patients. Latest clinical results out to two years demonstrated:
92% average acne inflammatory lesion count (ILC) improvement at 24 months compared to baseline.
77% of patients were acne medication-free at 24 months.
9% of patients received a topical acne drug and only 14% received a systemic acne drug during the follow-up period.
There were no serious or unanticipated adverse events.
Jill S. Waibel, MD, board-certified dermatologist practicing at the Miami Dermatology and Laser Institute, commented, "These 24-month results from the EU registry study provide us the first perspective of the long-term safety and durability of Sebacia Microparticles in acne patients. Sebacia Microparticles represents an option for dermatologists that is complementary to our polytherapy approach to acne while allowing us to target the sebaceous glands with a selective and local treatment."
The ongoing U.S. registry study was designed to evaluate acne outcomes in patients treated with Sebacia Microparticles in combination with the ongoing use of topical retinoids. In contrast to the EU registry study where all topical therapies were stopped prior to Sebacia treatment, patients in the U.S. study were able to continue topical therapy after their third Sebacia treatment at the discretion of the investigator. The study is being conducted at six non-academic clinical practices in the U.S. and to date, 72 patients have completed 3-month follow-up. Latest clinical results out to 3 months include:
65% average acne ILC improvement at 3 months from baseline. These findings are better than historically-reported ILC reduction at 3-months of about 40-50% without topical pre-treatment.
90% of the subjects were responders, defined as reduction of ILC of 40% or better.
Transient erythema (redness of the skin typical with laser use) was reported and patients were able to return to school or work immediately after the procedure. There were no serious or unanticipated adverse events.
Ashish Bhatia, MD, board-certified dermatologist practicing at Oak Dermatology in the greater Chicago area and Clinical Associate Professor at the Feinberg School of Medicine at Northwestern University, said, "I am pleased to see these 3-month results from the U.S. registry tracking similarly to the European registry study that was conducted previously. The real-world results provide clinicians with additional data about treating acne patients with Sebacia Microparticles who are already using topical retinoids, a common first-line therapy."
About Sebacia Microparticles
Sebacia Microparticles selectively targets the sebaceous (oil-producing) glands to treat acne at the source, offering dermatologists a truly innovative approach to acne therapy. In the U.S., Sebacia Microparticles was cleared in 2018 by the U.S. Food and Drug Administration (FDA) as a Prescription Use Product for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris.
Sebacia, Inc. is a private medical device and aesthetics company focused on creating advanced topical therapies for the treatment of dermatological conditions, with a primary focus on a novel procedure-based acne treatment. Sebacia's goal is to provide a better alternative to the daily use of topical and systemic drugs currently available for the treatment of acne. Sebacia's patented microparticles technology was invented at Rice University, and the proprietary dermatology applications were further developed with researchers from the Wellman Center of Photomedicine at Massachusetts General Hospital. Sebacia Microparticles is cleared for use in the U.S. and in the EU, the two largest dermatology markets in the world. Sebacia is commercially available to dermatologists in selected U.S. markets. In the EU, Sebacia Microparticles is sold in select markets. Investors in the company include Accuitive Medical Ventures, Domain Associates, Partners Innovation Fund, Salem Partners and Versant Ventures.