The following is a summary of “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,” published in the OCTOBER 2023 issue of Dermatology by Rosso, et al.
Historically, combining benzoyl peroxide (BPO) and tretinoin in a single formulation for acne treatment has been a complex task due to issues related to their chemical stability and potential for skin irritation. Microencapsulation, however, offers a promising solution to these challenges. For a study, researchers sought to thoroughly evaluate the effectiveness, safety, and tolerability of a novel 3% benzoyl peroxide/0.1% tretinoin cream formulation, encapsulated as E-BPO/T, for treating acne.
The research enrolled participants aged nine years and older with moderate to severe acne across two comprehensive, double-blind, vehicle-controlled, parallel clinical trials. These individuals were randomly assigned to receive daily treatment for 12 weeks, either with E-BPO/T (consisting of 571 subjects) or a control vehicle cream (287 subjects).
The study’s findings demonstrated the superiority of E-BPO/T over vehicle control in both trials. A greater number of subjects achieved success in the Investigator’s Global Assessment (IGA) with E-BPO/T (38.5% and 25.4%) compared to those who received the vehicle cream (11.5% and 14.7% P < .001/P = .017). In studies 1 and 2, the inflammatory lesion count for E-BPO/T changed from baseline at -21.6 versus -14.8 for vehicles (P <.001) and -16.2 versus -14.1 (P =.018), respectively. In trials 1 and 2, respectively, the changes from baseline in noninflammatory lesions for E-BPO/T were -29.7 versus -19.8 for vehicle (P< .001) and -24.2 versus -17.4 (P <.001). Both studies showed good tolerability for E-BPO/T.
E-BPO/T, with its unique microencapsulated formulation, offered statistically significant and clinically meaningful improvements in treating acne. It was found to be well-tolerated by individuals with moderate to severe acne, making it a promising therapeutic option in the battle against this common skin condition.