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 © 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
BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.
METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.
CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.
Clinicaltrials.gov registry: (NCT01880320)
J Drugs Dermatol. 2017;16(6):582-589.
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Acne vulgaris is the most frequently diagnosed dermatologic condition in the US among those between 5 and 44 years of age.1-2 With a large number of topical agents available to treat acne, it is becoming increasingly important to understand how various population segments may respond to acne therapies. Clinicians today have the opportunity to individualize treatment; however, achieving optimal results requires knowledge of how various agents perform in specific population segments. Acne is slightly more common and generally more severe in adolescent males but is becoming increasingly common among adult females.3,4 Reports have indicated that as many as 54% of adult females may have acne.4-7 Certain concerns are heightened among adult women with acne, including an often increased psychosocial burden of the disease and the potential for pregnancy.8,9 Adult female acne has traditionally been perceived as different from adolescent acne in clinical presentation, treatment response, and therapeutic concerns.7,8 Some women appear to respond more slowly to acne therapy, and hormonal and genetic factors may play a more prominent role in this setting compared with adolescent acne.10 However, a recent study that observed acne in 374 females over the age of 25 found that approximately 90% had acne that was similar in presentation to typical adolescent acne, suggesting that these women may respond well to the same acne therapies as their adolescent counterparts.7 Gender differences among acne subjects may be most prominent in adolescent subjects. Males with acne are at higher risk for truncal acne and scarring.11 In addition, acne can be more severe in males than in females during late adolescence.12 Males may be less likely to adhere to acne therapy, particularly if the regimen is complicated.13,14 They may also have lifestyle factors that could potentially reduce adherence to acne therapy by contributing to forgetting to apply medication or being too busy, such as participating in sports.13 Recommendations for treatment of adolescents (males or females) suggest a simple treatment regimen that is convenient for the patient’s daily routine.15 Adapalene, a retinoid, and benzoyl peroxide (BPO) have com- plementary and synergistic mechanisms of action that are