IMPORTANCE: Neocollagenesis can be achieved using a dermal rolling needle device, thereby reducing the appearance of acne scars. OBJECTIVE: To determine the efficacy of a needling device for treatment of acne scars. DESIGN, SETTING, AND PARTICIPANTS: We performed a single-center, rater-blinded, balanced (1:1), split-face, placebo-controlled, parallel-group randomized clinical trial at an urban academic institution. The study took place from November 30, 2009, through July 27, 2010. Twenty healthy adults (age range, 20-65 years) with acne scars on both sides of the face were enrolled. Fifteen individuals completed the study, and no enrolled participants were withdrawn for adverse effects. INTERVENTIONS: For each participant, one side of the face was randomized for needling. Three needling treatments were performed at 2-week intervals. MAIN OUTCOMES AND MEASURES: Two blinded dermatologists separately rated participants' acne scars based on standard digital photographs obtained at baseline and at the 3-month and 6-month follow-up visits on the quantitative global scarring grading system. RESULTS: Mean scar scores were significantly lower in the treatment group compared with baseline at 6 months (mean difference, 3.4; 95% CI, 0.2-6.5; P = .03) and nominally but not significantly lower compared with baseline at 3 months (mean difference, 2.4; 95% CI, -0.01 to 4.8; P = .052). In the control group, mean scar scores did not vary significantly from baseline at 3 months (mean difference, 1.0; 95% CI, -1.4 to 3.4; P = .96) and at 6 months (mean difference, 0.4; 95% CI, -2.3 to 3.5; P > .99). The needling procedure was not particularly painful, with a mean pain rating of 1.08 of 10. Participants perceived a 41% mean improvement in overall scar appearance on the treated side. No adverse events were reported. CONCLUSIONS AND RELEVANCE: After 3 needling treatments, there was improvement in the appearance of acne scars over time compared with the control group, with minimal pain reported. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00974870.
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