Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender

June 2017 | Volume 16 | Issue 6 | Original Article | 582 | Copyright © June 2017


Linda Stein Gold MD,a William P. Werschler MD,b Jennifer Mohawk PhDc

aDepartment of Dermatology, Henry Ford Hospital, Detroit, MI bDepartment of Medicine/Dermatology, University of Washington, Seattle, WA cGalderma Laboratories, L.P. Fort Worth, TX

Figure 4change in noninflammatory lesions (vs -32.4% for the vehicle group, P<0.001; Figure 5A) and subjects over age 18 experienced a mean -62.4% change (vs -34.8% for the vehicle group, P<0.001; Figure 5A). For inflammatory lesions, subjects age 12 – 17 years old in the A/BPO gel 0.3%/2.5% group experienced a mean -61.8% change (vs -39.9% for the vehicle group, P<0.001; Figure 5B) and subjects over age 18 experienced a mean -63.8% change (vs -26.5% for the vehicle group, P<0.001; Figure 5B).

Safety and Tolerability

A/BPO gel 0.3%/2.5% was safe and well tolerated in all groups, with no significant differences based on gender or age. Adverse events in this study were generally mild to moderate in severity, and most were unrelated to the study drug. Only 9.7% of A/BPO gel 0.3%/2.5% treated subjects had to adopt the modified every-other-day application. The most common adverse events occurring in ≥1% of subjects in the A/BPO gel 0.3% group included nasopharyngitis (n=14), gastroenteritis (n=3), skin irritation (n=9), eczema (n=3), and headache (n=3). Figure 6 presents mean tolerability scores for A/BPO 0.3% vs vehicle stratified by gender; in both genders, tolerability scores were highest at the week 1 assessment and diminished for the remainder of the study. By week 12, A/BPO gel 0.3%/2.5% tolerability scores were similar to or below baseline tolerability scores, and similar to or below week 12 vehicle scores.

DISCUSSION

The results of this study support the use of A/BPO 0.3%/2.5% as a first line and foundational acne therapy in subjects 12 and older, including both genders, adolescents, and adults. While acne has traditionally been seen as predominantly a disease of teenagers, the changing demographics of the disease are highlighting the need for acne treatments shown to be effective and safe in population sub-groups. This is perhaps particularly important in severe inflammatory acne, a patient population that comprised 50% of the subjects in the study.16 As shown in Table 1, the subjects in this study had a relatively high number of baseline lesions (98.5 total lesions in the A/BPO 0.3% group vs 65.5 - 79 total lesions in recent studies of other topical acne drugs).16,21,22 Gender can influence the experience of acne, and this should be considered when designing a treatment regimen. Differences in the impact of acne on the quality of life of women and men have been reported.9,23,24 A 2011 study of 211 subjects compared women and men and found that women reported a lower quality of life regardless of acne severity at the first clinical visit; further, women with moderate acne were more likely to receive aggressive acne therapy.23 Hassan et al reported women with acne had a more negative self-consciousness about appearance (P=0.001) and lower self-concept than men (P=0.004).9 In addition, the individual’s subjective rating of severity of their