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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.

Abstract

BACKGROUND

Patients 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.

OBJECTIVE

To compare BPO/C and AP with regard to the early effect on QOL, efficacy, and tolerability in patients with mild to moderate acne vulgaris.

METHODS

Patients 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.

RESULTS

A 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).

CONCLUSIONS

BPO/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.

Authors+Show Affiliations

Complutense University of Madrid, Madrid, Spain. auroraguerratapia@gmail.com

Source

MeSH

Acne Vulgaris
Adapalene
Adolescent
Adult
Benzoyl Peroxide
Child
Clindamycin
Drug Therapy, Combination
Female
Gels
Humans
Male
Naphthalenes
Quality of Life
Severity of Illness Index
Single-Blind Method
Surveys and Questionnaires
Treatment Outcome
Young Adult

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22648218

Citation

TY - JOUR T1 - 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. A1 - Guerra-Tapia,Aurora, PY - 2012/6/1/entrez PY - 2012/6/1/pubmed PY - 2013/5/15/medline SP - 714 EP - 22 JF - Journal of drugs in dermatology : JDD JO - J Drugs Dermatol VL - 11 IS - 6 N2 - BACKGROUND: Patients 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. OBJECTIVE: To compare BPO/C and AP with regard to the early effect on QOL, efficacy, and tolerability in patients with mild to moderate acne vulgaris. METHODS: Patients 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. RESULTS: A 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). CONCLUSIONS: BPO/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. SN - 1545-9616 UR - https://www.unboundmedicine.com/medline/citation/22648218/abstract/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_ L2 - https://medlineplus.gov/acne.html ER -