Abstract

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 42%), 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.

Highlights

  • A previous clinical trial evaluating autologous fibroblasts injections for the treatment of facial contour deformities found significantly greater improvements in wrinkle and acne scar appearance than with placebo treatment

  • Autologous fibroblast treatment was associated with significantly greater treatment success than vehicle control for the subject (43% vs 18%), evaluator (59% vs 42%), and independent photographic viewer (IPR) assessments

  • As expected given the diversity of acne scarring morphology and severity, certain treatment modalities are more effective with certain subgroups of scarring.[4]

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Summary

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. Distensible facial acne scars (scars disappearing completely with manual perilesional skin stretching) were targeted for treatment in this study. Evaluators were provided with a pictorial and descriptive guideline outlining the acne scarring morphology (depressed and distensible) considered for autologous fibroblast treatment.[16] Healthy subjects with facial acne scarring on both cheeks were enrolled in the study. Subjects’ depressed distensible acne scars on both cheeks had to be evaluator rated as moderate or severe on a novel, validated 5-point acne scar assessment scale (Table 1). Subjects were excluded if they had hypertrophic acne scarring or numerous icepick acne scars in the treatment area, had undergone

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