Local tolerance of acne vulgaris medications containing benzoyl peroxide (BPO) are not adversely affected by changing the formulation of the product, according to a study published in Journal of Drugs in Dermatology.
In this randomized, evaluator-blind, single-center, parallel-group study, participants aged 18 to 45 years with mild to moderate acne vulgaris (N=133) were randomly assigned to 1 of 3 topical product formulations containing BPO. The reformulations included a 4% BPO face wash (test product), a 10% BPO face wash (test product), or an older formulation of 10% BPO acne foaming wash (no longer commercially available, hereafter referred to as the reference product). Randomization was stratified by severity of the acne (investigator global assessment [IGA] grade 2/IGA grade 3) and use of contact lenses (use/nonuse), which allowed for 4 strata for randomization. Participants used the products at home twice per day for 21 days, including on the morning of the final visit, which was conducted under supervision at the study site. The product quantity was not specified, but was expected to be ≤2 g per application.
Assessments were conducted by a dermatologist and an ophthalmologist on the day of the first application and on the day of the final visit. The dermatological assessment of the face included erythema, dryness, desquamation/peeling, and edema. The ophthalmologist assessed conjunctiva involvement and lacrimal intensity. Participants were given diaries including 2 self-assessment questionnaires that they were required to complete on day 7 and day 14. Participants also conducted self-assessments of their face and eyes on the day of the first application and on the day of the final study visit.
Most participants had the same composite dermatologist score at both baseline and at day 21 in all 3 treatment groups (4% BPO: 32 [72.7%] participants; 10% BPO: 35 [79.5%] participants; reference product: 39 [86.7%] participants). Four participants had a higher composite dermatologist score at day 21 than at baseline. In the 4% BPO cleanser group, the composite dermatologist score changed by a mean of -0.08 (95% CI, -0.192 to 0.038) from baseline to day 21. In the 10% BPO group, this score changed from baseline to day 21 by a mean of 0.05 (95% CI, -0.021 to 0.121), and in the reference group, the score changed by -0.02 (95% CI, -0.105 to 0.059). Mean changes from baseline were comparable between the reference product and the test products in the composite ophthalmologist score and in participants’ self-assessment scores.
There appear to be no additional tolerability concerns in using the 2 reformulated BPO-containing face washes. These results are applicable for otherwise healthy adults with acne vulgaris of mild to moderate severity.
Disclosure: This study was funded by GlaxoSmithKline Consumer Healthcare. GlaxoSmithKline Consumer Healthcare provided the experimental products, was involved in the design and conduct of the study, prepared the statistical analysis plan, and performed the analyses. The authors are employees of GlaxoSmithKline.
Santos-Caetano JP, Cargill MR. A randomized controlled tolerability study to evaluate reformulated benzoyl peroxide face washes for acne vulgaris. J Drugs Dermatol. 2019;18(4):350-356.