Successful treatment of depressed, distensible acne scars using autologous fibroblasts: a multi-site, prospective, double blind, placebo-controlled clinical trial.

Background: A previous clinical trial evaluating autologous fibroblasts (human dermal) injections for the treatment of facial contour deformities found significantly greater improvements in wrinkle and acne scar appearance than with placebo treatment.

Objective: To compare the efficacy and safety of autologous fibroblast treatment of moderate to severe, depressed, distensible facial acne scars with that of vehicle control.

Methods: This was a randomized multicenter, double-blind, placebo-controlled trial in subjects with bilateral moderate to severe acne scarring; subjects served as their own controls. Skin biopsies were obtained from randomized subjects for fibroblast production. Subjects (n = 99) underwent three intradermal injection sessions with 2 mL of autologous fibroblast suspension (10-20 million cells/mL) on one cheek and vehicle control (cell culture medium) on the other at 14-day intervals. Efficacy was based on the blinded subject's, evaluator's, and independent photographic viewer's (IPR) assessment of acne scarring 1 to 4 months after the last treatment.

Results: Autologous fibroblast treatment was associated with significantly greater treatment success than vehicle control for the subject (43% vs.18%), evaluator (59% vs. 2%), and IPR assessments. Autologous fibroblast injections were well tolerated, without permanent adverse effects.

Conclusions: Autologous fibroblast injections safely and effectively improved the appearance of depressed distensible acne scars.