Observational Study of Clindamycin Phosphate and Tretinoin Gel for the Treatment of Acne
April 2019 | Volume 18 | Issue 4 | Original Article | 328 | Copyright © April 2019
Johan Ohlson PhD,a Rada Dakovic PhD,b Mats Berg MDc,d
aMylan AB, Solna, Sweden bMylan, Bad Homburg, Germany cUppsala University, Uppsala, Sweden dSkindoc, Danderyd, Sweden
Abstract
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 equals 0.0004 at week 4; P less than 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.
INTRODUCTION
Acne vulgaris (acne) is a chronic inflammatory disease of the human sebaceous follicle.1 It is one of the most common skin diseases, affecting approximately 85% of adolescents.2 There are several clinical features of acne, including: excess grease (ie, seborrhea), inflammatory lesions, non-inflammatory lesions, and various degrees of scarring.1 Despite not being a life threatening or physically debilitating disease, acne can cause substantial pain and discomfort,3,4 and have a significant impact on patients’ quality of life (QOL).3-5In a qualitative analysis, it was found that acne can impact emotional functioning, social functioning, relationships, leisure activities, daily activities, sleep, and school/work.3 Impairments in mental health and social functioning in patients with acne have been reported to be worse than in patients with chronic debilitating diseases such as asthma, epilepsy, diabetes, back pain, or arthritis.5 A population survey in Greece stated that the impact of acne on QOL was proportional to its severity, with a higher incidence of emotional issues (eg, low self-esteem, poor body image, and impairment of relationships with others) associated with severe acne.4 As such, QOL should be considered when reviewing treatment options for patients with acne.Recommendations for acne treatment depend on the severity of the disease.6,7 For comedonal acne, both European and Swedish guidelines recommend treatment with adapalene alone.6,7 Treatment recommendations for mild papulopustular acne in Sweden include benzoyl peroxide (BPO) plus adapalene or monotherapy with BPO, adapalene, or azelaic acid, while first- and second-choice recommendations for moderate papulopustular acne are BPO plus adapalene, BPO plus clindamycin, or tretinoin plus clindamycin;6 European guidelines are in line with these recommendations for treatment of mild-to-moderate papulopustular acne.7 In both European and Swedish guidelines, treatment with a systemic antibiotic in combination with topical treatment is primarily reserved for severe cases of acne.6,7
