Acne Scar Treatment Study Sent To FDA

Fibrocell Science, a biotechnology company based in Exton PA, working on the development of autologous cell therapies submitted a clinical study report to the FDA, on it’s acne scar treatment.

The company says thorough analysis of study data contained in the report demonstrates that the study was statistically significant, and a significant regulatory milestone for the Company.

The Phase II/III, placebo-controlled study investigating the efficacy and safety of azficel-T for the treatment of moderate to severe acne scars evaluated a total of 109 individuals at seven U.S. clinical sites. In the study, both the Patient and Evaluator assessments met the co-primary endpoints four months after the final study treatment, and were statistically significant, achieving p-values of <0.0001 and 0.0109, respectively (p-values less than or equal to 0.05 are considered statistically significant).

“This is an important step towards another potential indication for our azficel-T lead therapy, which is currently under review by the FDA for use in the treatment of nasolabial fold wrinkles. Our therapy would be the first product of its kind available to address the large unmet need in treatment of acne scars, if approved by FDA.”

Chairman and CEO David Pernock

Acne Scars

The company says 43 percent of patients reported a response to the side of the face treated with azficel-T four months after the final study treatment, while 18 percent of patients reported a response on the placebo-treated side of the face. With respect to the Evaluator assessments, evaluators reported that 59 percent of patients responded on the side of the face treated with azficel-T, and that 42 percent of patients responded on the placebo-treated side of the face. Notably, significant improvement was also observed as soon as one month after the final azficel-T treatment.

Acne Scar Treatment Side Effects

No serious adverse events related to azficel-T were reported during the course of the Acne Scar Treatment study. Similar to the results from previous studies with azficel-T, the occurrence of local adverse event in this study was low, and the events reported were mostly mild in nature and of short duration.

“This is a unique product and may be life changing for patients with acne scarring,” said Girish Munavalli, M.D., MHS, Medical Director, Dermatology, Laser and Vein Specialists of the Carolinas, Charlotte, North Carolina. “I remain extremely excited about the study results and the activity seen with the use of azficel-T to treat acne scars. Since the study concluded, some of the study patients have returned to my clinic. During these visits, I have noticed sustained improvement in the appearance of their scarring, which I believe is the result of the azficel-T treatment administered during the clinical trial. Based on these observations and my overall experience with azficel-T, I am very positive about the use of Fibrocell’s product for this indication.”

Information for this Acne Scar Treatment story came from a Fibrocell Science, Inc press release.

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