Sebacia EU Real-World Results Demonstrate an Average 79% Improvement in Acne at 6 Months
DULUTH, Ga., Oct. 11, 2018
DULUTH, Ga., Oct. 11, 2018 /PRNewswire/ -- Sebacia, Inc., a privately held, commercial stage dermatology and aesthetics company, today announced that its real-world, pre-conditioning registry trial in Europe demonstrated that the combination of pre-conditioning followed by Sebacia Microparticles led to an average 79% improvement in facial acne through six months of follow-up. The skin pre-conditioning regimen was designed to test the hypothesis that preparing the skin by clearing the pores would allow greater delivery of Sebacia's gold microparticles and lead to improved clinical outcomes.
The results were presented by Dr. Ashish Bhatia, MD, dermatologist, internationally recognized expert in dermatologic surgery and cosmetic surgery, and Associate Professor of Clinical Dermatology at Northwestern University, Feinberg School of Medicine in Chicago, IL, in an oral presentation titled OA145 "Acne Treatment with Pre-Conditioning and Selective Photothermolysis of Sebaceous Follicles with Gold Microparticles and Laser" during the American Society for Dermatologic Surgery (ASDS) 2018 Annual Meeting.
The ongoing single-arm registry study conducted at nine commercial practices in Europe includes 71 patients with mild to moderate inflammatory facial acne. The study evaluates the impact of a short skin pre-conditioning period consisting of 2-4 weeks of daily topical application of a gel containing 0.1% adapalene and 2.5% benzoyl peroxide. Patients are then administered three weekly in-office treatments of Sebacia Microparticles.
Key results include:
- At 3 months, the mean acne inflammatory lesion count (ILC) improvement was 66% from baseline and at 6 months, ILC further improved to 79% from baseline. These findings are significantly better than historically-reported ILC reduction at 3-months of 49% and at 6-months of 65% without pre-conditioning.
- 63% of patients had in Investigator Global Assessment (IGA) score of clear or almost clear at 6 months.
- 76% of patients were acne medication-free at 3 months and 61% at 6 months.
- 29% of patients received a topical prescription and only 10% received a systemic drug during the 6-month follow-up period. In fact, 90% of patients were managed through 6 months without systemic medications.
- 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.
Anthony Lando, Chief Executive Officer, said, "The positive results from our ongoing registry study in Europe have powerful implications in the U.S. now that Sebacia Microparticles is FDA-cleared. The poly-therapy approach of combining real-life pre-conditioning followed by Sebacia Microparticles with laser represents an innovative new in-office treatment for mild to moderate facial acne, especially as it may help avoid progression to second- and third-line treatments, including systemic acne medications."
FDA-cleared Sebacia Microparticles selectively targets the sebaceous (oil-producing) glands, offering dermatologists a truly innovative approach to acne therapy. In the U.S., Sebacia Microparticles was recently cleared by the U.S. Food and Drug Administration (FDA) 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. In the EU, Sebacia Microparticles is CE marked and sold in select markets.
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. Investors in the company include Accuitive Medical Ventures, Domain Associates, Partners Innovation Fund, Salem Partners and Versant Ventures.
SOURCE Sebacia, Inc.