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
June 2012 | Volume 11 | Issue 6 | Original Article | 714 | Copyright © 2012
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.
J Drugs Dermatol. 2012;11(6):714-722
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Combination therapy is frequently used in the treatment of mild-to-moderate inflammatory acne vulgaris and has been associated with better outcomes compared with single-agent therapy.1-3 Options for topical combination therapy include an antibiotic with benzoyl peroxide (BPO) or a retinoid, or BPO + retinoid. Such combinations maximize the additive effects of agents with different but complementary mechanisms of action, targeting different aspects of the pathophysiological process.2,3 One such combination in current use is clindamycin 1% (C) with BPO 5%, in a formulation that contains hydrating excipients such as dimethicone and glycerin (UK PI Duac®)4 to limit the irritation associated with BPO.5 The combination of an antibiotic and BPO suppresses the follicular population of P. acnes faster and to a greater degree than do topical antibiotics alone and reduces the risk of developing resistant strains of P. acnes.6 In vivo data demonstrate that, after 1 week of use, the combination of BPO/C rapidly reduces total numbers of P. acnes by 99.8% compared with reductions ranging from 30% to 62% with different formulations of clindamycin monotherapy.7
Topical retinoids are another option for the treatment of inflammatory acne. These agents normalize desquamation of the follicular epithelium and prevent comedone formation.1,8 Among the topical agents available, adapalene (AP) appears to cause less irritation than either tretinoin or tazarotene.1 Data from a single-blind, multicentre study in 130 patients with mild-to-moderate acne vulgaris indicate that the combination of BPO/C is clinically more effective than AP gel (Differin®; Galderma, Watford, UK) with regard to producing greater reductions in the number of inflammatory lesions (P<0.001) and total lesions (P<0.004) from week 1 onward over a 12-week period.
It is now recognized that patients with acne have impaired quality of life (QOL) that is comparable to the impairment reported by patients with other chronic conditions (eg, asthma, back pain).9 Moreover, the impact of acne on QOL is not correlated with objective assessments of severity, so that it is often difficult for physicians to assess the impact of disease on QOL.6,9 Therefore, it is important to investigate the impact of treatment on QOL as well as on clinical symptoms of acne. The current study (NCT00688519 and NCT00689481 on www.clinicaltrials.gov) aimed to compare the impact on QOL, clinical efficacy, and tolerability of BPO/C applied once daily compared with AP applied once daily in the treatment of mild to moderate acne vulgaris. QOL was assessed using the Skindex-29 questionnaire, which evaluates QOL across 3 domains: emotional, functional, and symptomatic.10 This instrument has shown good psychometric properties (eg, internal consistency, reproducibility, construction and content validity, feasibility, and sensitivity to change).10,11