Efficacy and Safety of Microencapsulated Benzoyl Peroxide and Microencapsulated Tretinoin for the Treatment of Acne Vulgaris: Results from Two Phase 3 Double-Blind, Randomized, Vehicle-Controlled Studies
Document Type
Journal Article
Publication Date
6-23-2023
Journal
Journal of the American Academy of Dermatology
DOI
10.1016/j.jaad.2023.05.093
Keywords
BPO; acne; acne vulgaris; benzoyl peroxide; microencapsulated; microencapsulation; retinoid; topical; tretinoin
Abstract
BACKGROUND: Benzoyl peroxide and tretinoin are commonly prescribed acne treatments. Historically, they have been difficult to combine in a single formulation due to chemical instability, and both medications are potentially irritating. Microencapsulation helps overcome these challenges. OBJECTIVE: Examine efficacy, safety, and tolerability of encapsulated BPO/encapsulated tretinoin (E-BPO/T) cream, 3%/0.1%. METHODS: Subjects ≥9 years old with moderate to severe acne were enrolled in 2 multicenter, double-blind, vehicle-controlled, parallel trials and randomized (2:1) to 12 weeks of once-daily E-BPO/T (n=571) or vehicle cream (n=287). RESULTS: E-BPO/T was significantly superior to vehicle in both studies, with more subjects achieving IGA success with E-BPO/T (38.5%/25.4%) versus vehicle (11.5%/14.7%; P<.001/P= .017). The change from baseline in inflammatory lesion count for E-BPO/T was -21.6 versus -14.8 for vehicle (P<.001) in study 1 and -16.2 versus -14.1 (P=.018) in study 2. The changes from baseline in noninflammatory lesions for E-BPO/T were -29.7 versus -19.8 for vehicle (P<.001) and -24.2 and -17.4 (P<.001) in studies 1 and 2, respectively. E-BPO/T was well tolerated in both studies. LIMITATIONS: Long-term data are not available. CONCLUSION: E-BPO/T provided statistically significant and clinically relevant improvements in IGA and inflammatory and noninflammatory lesion counts and was well tolerated in subjects with moderate to severe acne.
APA Citation
Del Rosso, James; Sugarman, Jeffrey; Green, Lawrence; Lain, Theodore; Levy-Hacham, Ofra; Mizrahi, Rinat; and Stein Gold, Linda, "Efficacy and Safety of Microencapsulated Benzoyl Peroxide and Microencapsulated Tretinoin for the Treatment of Acne Vulgaris: Results from Two Phase 3 Double-Blind, Randomized, Vehicle-Controlled Studies" (2023). GW Authored Works. Paper 2689.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/2689
Department
Dermatology