Observational Study of Clindamycin Phosphate and Tretinoin Gel for the Treatment of Acne.

INTRODUCTION

Acne vulgaris can cause pain/discomfort and have a negative impact on quality of life (QOL). Clin-RA is an acne treatment consisting of clindamycin phosphate 1.2% and tretinoin 0.025%, which has been proven effective and well tolerated in clinical studies. This prospective, non-interventional study aimed to capture data on previous treatment, acne severity, and QOL in patients with acne treated with Clin-RA and assess the efficacy and tolerability of Clin-RA in routine clinical practice.

METHODS

The study was performed at 18 centers in Sweden and enrolled patients aged ≥15 years with acne, who were prescribed Clin-RA for the first time. The observation period was ~12 weeks. The primary objective was to assess the patient’s perception of their facial acne severity before and during Clin-RA treatment using a visual analog scale (VAS; 100 mm scale). Secondary objectives included QOL evaluation before and after treatment, using the Dermatology Life Quality Index (DLQI) questionnaire.

RESULTS

84 patients were enrolled and eligible for analyses (79.8% female; mean age 22.6 years). Patient-assessed VAS scores for acne severity decreased continuously during the study, indicating improvement: the median percentage reduction from baseline for VAS score was 17.6% at week 4 and 63.8% at week 12, with changes from baseline being statistically significant (P=0.0004 at week 4; P<0.0001 at weeks 8 and 12). Overall, QOL improved after Clin-RA treatment, reflected by a decrease in the mean (standard deviation) DLQI sum score from 8.8 (5.8) on day 0 to 4.9 (4.2) at week 12. Seventy percent of patients were satisfied/very satisfied with treatment. Clin-RA was well tolerated, with no serious adverse drug reactions reported.

CONCLUSIONS

Treatment with Clin-RA resulted in continuous improvement of facial acne over the course of 12 weeks, along with improved QOL and a tolerable safety profile, supporting the use of Clin-RA in clinical practice. J Drugs Dermatol. 2019;18(4):328-334.