The Efficacy and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Patients With Facial Acne Vulgaris: Gender as a Clinically Relevant Outcome Variable
April 2015 | Volume 14 | Issue 4 | Original Article | 381 | Copyright © April 2015
Julie C. Harper MD
The Dermatology and Skin Care Center of Birmingham, Birmingham, AL
OBJECTIVE: To investigate whether treatment differences exist in male and female patients with moderate to severe acne treated with
clindamycin phosphate 1.2%/BP 3.75% gel or vehicle as monotherapy.
METHODS: A post hoc analysis comparing the efficacy and cutaneous tolerability in 498 male and female patients with moderate to
severe acne receiving clindamycin phosphate 1.2%/BP 3.75% gel, or vehicle for 12 weeks.
RESULTS: The efficacy of clindamycin phosphate 1.2%/BP 3.75% gel was greater than vehicle (P
>.001) in both genders. Within the clindamycin
phosphate 1.2%/BP 3.75% gel group, the mean percent change from baseline in inflammatory and noninflammatory lesion counts
was greater among females than males, as was the percentage of subjects who achieved a 2-grade reduction in the EGSS (P
LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients.
CONCLUSIONS: Clindamycin phosphate 1.2%/BP 3.75% gel provides statistically significant greater efficacy than vehicle with a favorable
safety and tolerability profile. It appears to be more effective in female patients.
J Drugs Dermatol.
There has been increased interest in possible gender differences
in females and males when it comes to acne
vulgaris and its treatment.1 Female acne patients have
been shown to report worse quality of life than male patients.2
Nodulocystic acne is more prevalent in adolescent male patients;
3 while acne on the lower face and jawline, and the clinical
cyclical flaring of lesions may be associated with hormonally
medicated acne in females.4
Evidence now suggests that there may be gender-based differences
in response to acne treatment. A study with dapsone 5%
gel suggested that females experienced a significantly greater
reduction in acne lesions compared to male acne patients after
12 weeks treatment. There were no gender difference in
the low incidence of adverse events (AEs) reported.5 A post
hoc analysis reported at the same time with clindamycin phosphate
1.2%/BP 2.5% gel also looked at gender differences, as
well as stratifying by age.6 Here the net reduction in lesion
counts (active minus vehicle) was much greater in the adolescent
population; and treatment success favored older males
and adolescent females.6
Recently, efficacy and tolerability data on a new fixed combination
product, clindamycin phosphate 1.2%/BP 3.75% gel, was
reported.7 A post hoc analysis of efficacy and cutaneous tolerability was conducted to examine any differences between
gender in those moderate to severe acne subjects treated with
clindamycin phosphate 1.2%/BP 3.75% gel or vehicle.
A total of 498 patients with moderate to severe acne vulgaris
were randomized (1:1) to receive clindamycin phosphate 1.2%/
BP 3.75% gel or vehicle in a multicenter, double-blind, vehiclecontrolled,
12-week, 2-arm study. Studies were conducted in
accordance with the Declaration of Helsinki and Good Clinical
Practices and in compliance with local regulatory requirements.
All patients provided written informed consent before entering
the study. Subjects were stratified by severity of acne (Evaluator’s
Global Severity Score [EGSS], ranging from 0 [clear] to 5
[very severe]). They were dichotomized into a moderate (EGSS
of 3) and a severe acne group (EGSS of 4).
The post hoc analysis compared data between clindamycin phosphate
1.2%/BP 3.75% gel and vehicle in male and female subjects.
Patients included males and females of any race or ethnicity
with moderate to severe acne, presenting with 20 to 40
inflammatory lesions (papules, pustules, and nodules), 20 to