Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial.

IMPORTANCE

Evidence is robust for the effectiveness of microneedle therapy in the management of postacne atrophic scarring. A home-based topical treatment with an efficacy comparable to microneedling would be a useful addition in the armamentarium of acne scar management.

OBJECTIVE

To compare the efficacy of topical tazarotene gel, 0.1%, with microneedling therapy in the management of moderate to severe atrophic acne scars.

DESIGN, SETTING, AND PARTICIPANTS: Prospective, observer-blinded, active-controlled, randomized clinical trial with 6 months of follow-up conducted between June 2, 2017, and February 28, 2018, at a tertiary care hospital in India. Thirty-six patients with grade 2 to 4 facial atrophic postacne scars and without a history of procedural treatment of acne scars within the previous year were recruited. Analyses were conducted using data from the evaluable population.

INTERVENTIONS

Both halves of each participant's face were randomized to receive either microneedling or topical tazarotene therapy. Microneedling was conducted on 1 side of the face with a dermaroller having a needle length of 1.5 mm for a total of 4 sessions during the course of 3 months. Participants were instructed to apply topical tazarotene gel, 0.1%, to the other side of the face once every night during this same period.

MAIN OUTCOMES AND MEASURES

Patients were followed up at 3 and 6 months by a blinded observer, and improvements in acne scar severity based on Goodman and Baron quantitative and qualitative scores and a subjective independent dermatologist score (range, 0-10, with higher scores indicating better improvement) were assessed. Patient satisfaction was assessed using a patient global assessment score (ranging from 0 for no response to 10 for maximum improvement) at these follow-up visits.

RESULTS

There were 36 participants (13 men and 23 women; mean [range] age, 23.4 [18-30] years), and the median (interquartile range [IQR]) duration of acne was 6 (4-8) years. For the 34 participants included in the complete data analyses, the median (IQR) quantitative score for acne scar severity at the 6-month follow-up visit following treatment with either tazarotene (from a baseline of 8.0 [6.0-9.8] to 5.0 [3.0-6.0]) or microneedling (from a baseline of 7.0 [6.0-10.8] to 4.5 [3.0-6.0]) indicated significant improvement (P < .001) that was comparable for both treatments (median [IQR] change in severity score from baseline, 2.5 [2.0-4.0] vs 3.0 [2.0-4.0]; P = .42). By contrast, median qualitative acne scar scores were the same for both treatment groups at baseline and did not significantly change following either treatment.

CONCLUSIONS AND RELEVANCE

The present clinical trial showed comparable outcomes of both treatments for the overall improvement of quantitative facial acne scar severity.

LEVEL OF EVIDENCE

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT03170596.