Murad Alam1, Sandra Han2, Marisa Pongprutthipan2, Wareeporn Disphanurat2, Rohit Kakar2, Michael Nodzenski2, Natalie Pace2, Natalie Kim2, Simon Yoo2, Emir Veledar3, Emily Poon2, Dennis P West2. 1. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois2Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois3Department of Surgery, Feinberg School of Medicine, No. 2. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 3. Department of Medicine, Emory University School of Medicine, Atlanta, Georgia5Center for Research and Grants, Baptist Health South Florida, Miami.
Abstract
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 Fifteen individuals completed the study, and no enrolled participants were withdrawn for adverse effects.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.
RCT Entities:
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.