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

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. 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.

© 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Figures

Figure 1

Treatment was performed using a 28 G tuberculin syringe. Note the superficial nature of the needle placement, below and surrounding each identifiable scar in the field. The endpoint of this injection is a visible wheal with blanching (276 × 162 mm; 72 × 72 dots per inch).

Figure 2

Efficacy assessments as a function of time: subjects and physician evaluators rated acne scar appearance of both cheeks 1 to 4 months after three treatments using autologous fibroblast and vehicle control as described in the Materials and Methods section. Subjects and evaluators were blinded to the treatment received on each cheek. The percentages of responders based on the subject assessment (A) are shown for autologous fibroblast– (filled squares) and vehicle control–treated (open squares) cheeks. The percentages of responders based on the evaluator assessment (B) are shown for autologous fibroblast–(filled circles) and vehicle control–treated (open circles) cheeks. A responder is defined as a 2-point improvement from baseline on the subject assessment and a 1-point improvement from baseline on the evaluator assessment. *Statistically significant difference between autologous fibroblast and vehicle control treatment based on the McNemar paired test of proportions (p < .05) (40 × 54 mm; 300 × 300 dots per inch).

Figure 3

Clinical response. Subjects received three treatments on the left cheek subunit with autologous fibroblasts at 2-week intervals as described in the Materials and Methods section. Shown are sample photographs of a subject taken before (A) and 4 months after (B) treatment with autologous fibroblasts. The control side on the right cheek subunit is shown in monographs before (C) and 4 months after (D) treatment (52 × 45 mm (300 × 300 dots per inch).

Figure 4

Sustained response noted from subject on the autologous fibroblast–treated left cheek 2 years after the last study treatment: (A) baseline, (B) 2 years after treatment (54 × 39 mm; 300 × 300 dots per inch).

Figure 5

Sustained response from subject BJ on the control side right cheek 2 years after the last study treatment: (A) baseline, (B and C) 2 years after treatment (54 × 27 mm; 300 × 300 dots per inch).

Figure 6

Sustained response from autologous fibroblast–treated cheek on study subject 2.5 years after final study treatment: (A) baseline, (B) 2.5 years after treatment (54 × 39 mm; 300 × 300 dots per inch).