Efficacy and Tolerability of a Fixed Combination of Clindamycin Phosphate (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate and Severe Acne Vulgaris Subpopulations

September 2015 | Volume 14 | Issue 9 | Original Article | 969 | Copyright © September 2015

Linda Stein Gold MD

Henry Ford Hospital, Detroit, MI

OBJECTIVE: To evaluate the efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in the treatment of moderate and severe acne.
METHODS: Multicenter, double-blind study in 498 patients with moderate or severe acne randomized to clindamycin-BP 3.75% or vehicle, once-daily for 12 weeks. Efficacy evaluations included inflammatory and noninflammatory lesion counts and evaluator’s global severity at baseline, and at weeks 4, 8, and 12. Adverse events (AEs) and tolerability were also assessed. This was a post hoc analysis of moderate and severe acne populations.
RESULTS: Clindamycin-BP 3.75% significantly reduced inflammatory and noninflammatory lesions in both moderate and severe acne patients compared with vehicle. More than half of the patients with severe acne (55.1%) had at least a 2-grade reduction in evaluator’s global severity score by week 12, and 30.6% of patients assessed their acne as ‘clear’ or ‘almost clear’. Clindamycin-BP 3.75% was well tolerated, with no substantive differences from vehicle; and no patient discontinued due to AEs.
CONCLUSIONS: Clindamycin-BP 3.75% aqueous gel is an effective and well-tolerated once-daily topical treatment for both moderate and severe acne

J Drugs Dermatol. 2015;14(9):969-974.


Acne vulgaris (acne) remains commonplace in dermatology practice. Lifetime prevalence estimates range from 73.3% to almost 100%.1,2 Although acne occurs most frequently in adolescence, it can persist into the 20s in around 64% of individuals and in 43% of people in their 30s.3 In addition, late-onset disease is not uncommon, with 18% of adult women found to have acne for the first time in one study.4
Moderate-to-severe acne affects around 20% of young people.5 Severity correlates with pubertal maturity, with the prevalence of severe acne steadily increasing from ages 11 to 17 years.6 Acne occurs earlier and is more severe in those with a positive family history (P<.0005).5 Increased acne severity was significantly associated with increased stress levels (P<.01).7 Seborrhea, the premenstrual phase, and dietary influences have been reported as risk factors for moderate-to-severe disease.5
Although acne can have a great impact on patients’ lives, often independent of severity,8,9 severe acne is associated with increased depression, anxiety, poor self-image, and poor self-esteem.10,11 Suicidal ideation is more common in those with severe acne compared with mild acne.12 Those with moderate-to-severe acne are also at increased risk of unemployment.13
Effective acne treatment is important for reducing both severity and potential recurrence. Topical therapies remain the most common and effective treatment option for mild-to-moderate acne, and also as maintenance therapy for all levels of acne severity.14 In addition, fixed combinations (eg, benzoyl peroxide (BP) and antibiotic, retinoid and antibiotic or BP) have been studied as monotherapy in moderately severe disease, and are considered the standard of care for patients with both comedonal and inflammatory acne, simplifying treatment regimens and reducing dosing frequency.15
Recently, efficacy and tolerability data was reported on a new fixed combination product, clindamycin phosphate 1.2% (clindamycin)-BP 3.75% aqueous gel.16 Here we present separate efficacy and safety analyses in the subpopulation of patients with either moderate or severe acne at baseline.


Detailed methodology has already been reported elsewhere;16 however, a summary is provided below.