Sebacia, Inc., a company dedicated to delivering breakthrough topical treatments to advance dermatology, has announced the presentation of positive clinical results from two independent studies conducted in Europe investigating the use of Sebacia gold microparticles to treat acne. The microparticles are proprietarily designed to be used with an approved dermatology laser to reduce the size and activity of sebaceous glands and follicles, which are responsible for acne.
"These two European clinical studies show that our Sebacia treatment provides a robust and significant reduction in the appearance and occurrence of inflammatory acne lesions, and the treatment is well tolerated," said Anthony Lando, Sebacia's CEO. "The positive results from these two European clinical trials support our efforts to obtain regulatory approvals in Europe and further inform our ongoing clinical trial in the United States."
The two studies evaluated Sebashell treatment in a total of 97 people with acne. The studies were designed as 1:1 randomization with crossover control groups. The control arm in the first study was over-the-counter face wash and in the second study was the suspension without Sebacia microparticles and laser treatment.
Results showed significant reduction in inflammatory lesions and IGA scores in the treated arm versus the control arms at 12 weeks post baseline in both studies. Inflammatory lesion count reduction was approximately 60 percent at six months post baseline, indicating robust durability. Treatment was well tolerated, and side effects were limited to transient mild erythema (redness) and mild edema (swelling). The data were presented at the 5CC Congress in Hong Kong on December 12, 2014.
The principal investigator of the studies, Dr. Witold Owczarek, said:
Sebacia treatment provided a significant and sustained reduction in acne for the patients in our clinical trial. As a simple, two-step, in-office treatment, Sebacia treatment could provide an essential alternative to the daily use of topical and systemic drugs that are currently available for acne.