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Effects of benzoyl peroxide 5% clindamycin combination gel versus adapalene 0.1% on quality of life in patients with mild to moderate acne vulgaris: a randomized single-blind study.
BACKGROUNDPatients with acne vulgaris often have impaired quality of life (QOL). The fixed-dose combination of benzoyl peroxide 5%/clindamycin 1% gel (BPO/C) topical gel provides an earlier onset of action and is more effective against inflammatory and total facial lesions than adapalene (AP) 0.1% gel.
OBJECTIVETo compare BPO/C and AP with regard to the early effect on QOL, efficacy, and tolerability in patients with mild to moderate acne vulgaris.
METHODSPatients were randomized to BPO/C or AP once nightly for 12 weeks in a multicentre, single-blind trial. The primary efficacy endpoint was QOL at week 2, assessed using the Skindex-29 questionnaire. Secondary endpoints included grading and counting of acne lesions; investigator assessments of peeling, erythema, and dryness, and patient-reported burning or itching. Adverse events were monitored during the study and during the 14-day minimum follow-up period.
RESULTSA total of 168 patients were enrolled, and 114 patients completed the study. In the intent-to-treat population, after 2 weeks of treatment, BPO/C was associated with a small but noticeably better improvement in global QOL compared with AP (-4.9 versus -1.1; P<0.001). A greater reduction in both total and inflammatory lesions was noted from week 1 onward (P<0.05) with BPO/C versus AP. At all time points, BPO/C was better tolerated than AP for all investigator-rated (dryness, peeling, erythema) and patient-rated (burning, itching) events (P<0.036).
CONCLUSIONSBPO/C is associated with early improvements in QOL compared with AP. These QOL improvements are likely to be the result of better efficacy and tolerability outcomes observed with BPO/C.
Complutense University of Madrid, Madrid, Spain. firstname.lastname@example.org
Journal of drugs in dermatology : JDD 11:6 2012 Jun pg 714-22
Drug Therapy, Combination
Quality of Life
Severity of Illness Index
Surveys and Questionnaires
Pub Type(s)Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't