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

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.

Automated summary

This study demonstrated the efficacy and safety of encapsulated benzoyl peroxide/tretinoin (E-BPO/T) cream in the treatment of acne, overcoming the limitations of chemical instability and potential irritation associated with these medications.