Clindamycin phosphate 1.2% and tretinoin 0.025% (Clin-RA) gel is safe and effective for use in real-life clinical practice for the rapid and continuous improvement of acne severity and improved quality of life in patients with facial acne, according to a study published in the Journal of Drugs in Dermatology.
The investigators of this prospective, non-interventional study sought to assess previous acne treatment, acne severity, and quality of life in patients with acne vulgaris taking Clin-RA gel, and to evaluate the efficacy and tolerability of the gel to treat acne in real-life clinical practice.
The study included 84 patients ≥15 years of age from 18 centers in Sweden who had facial acne and were prescribed Clin-RA for the first time. The followup period was approximately 12 weeks and the primary objective was to gauge the patients’ perception of their acne severity before and while receiving Clin-RA treatment using a visual analog scale (0=no acne, 100=extremely severe acne). A secondary outcome measure was evaluation of patients’ quality of life scores reported before and after receiving Clin-RA treatment, using the Dermatology Life Quality Index (DLQI) questionnaire. Efficacy analyses were conducted on the overall study population as well as on subpopulations stratified for age, gender, localization of acne, and acne severity. Adverse events and safety profiles were also reported in patients treated with Clin-RA.
The results showed improvement in acne severity, in which the patient-assessed visual analog scale scores decreased continuously and significantly throughout the study: the median percentage reduction in scores from baseline was 17.6% at week 4 (P =.0004) and 63.8% at week 12 (P <.0001). Changes in acne severity were similar when the study group was stratified according to subpopulations. Overall, the participants’ quality of life scores improved after receiving Clin-RA treatment: the investigators observed a decrease in the mean DLQI scores from 8.8 (standard deviation 5.8) at baseline to 4.9 (standard deviation 4.2) at week 12. Patient satisfaction data were collected for 50 patients at week 12, of which 70% reported being satisfied/very satisfied with treatment. Only 2 patients reported adverse events from treatment, and none were considered serious.
Limitations to the study included a relatively small sample size of patients from Sweden, preventing the generalizability of the study findings to broader populations. Patient assessments of acne severity and quality of life were documented using a diary card and DLQI questionnaire, respectively, and several participants failed to return their cards or questionnaires by mail at the end of the study.
The investigators suggest that Clin-RA gel is effective and well tolerated in the real-life treatment of acne vulgaris, in which patients with facial acne experienced continuous improvement over 12 weeks of treatment and reported improved quality of life scores. These findings support the safety and efficacy of Clin-RA use in clinical practice.
This study was sponsored by Meda, a Mylan company.
Ohlson J, Dakovic R, Berg M. Observational study of clindamycin phosphate and tretinoin gel for the treatment of acne. J Drugs Dermatol. 2019;18(4):328-334.