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

Article

Publication Date

6-23-2023

Publication Title

Journal of the American Academy of Dermatology

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.

PubMed ID

37356627

ePublication

ePub ahead of print

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