Background: Acne vulgaris has a multifactorial pathogenesis, and combination therapy is recommended in most patients. A tretinoin 0.1%/benzoyl peroxide 3% (Tret-BPO) cream which uses a core-shell encapsulation system to enhance the stability of both active ingredients recently received approval from the Food and Drug Administration (FDA).
Objective: To review the pharmacokinetics, efficacy, and safety of recently approved Tret-BPO.
Methods: A review of literature was conducted using the EMBASE, MEDLINE (Pubmed), and Clinicaltrials.gov databases in December 2021. Articles in English discussing the use of Tret-BPO in the treatment of acne vulgaris were included.
Results: In a phase 2 trial, Tret-BPO achieved Investigators Global Assessment (IGA) success more often (39.7%) than vehicle (12.3%; P<0.001). In 2 phase 3 trials, Tret-BPO had a higher success rate (Trial 1: 38.5% and Trial 2: 25.4%) when compared with vehicle (Trial 1: 11.5% and Trial 2: 14.7%; P<0.001 and P=0.017).
Limitation: This review was limited by the lack of clinical trials assessing the efficacy and safety of Tret-BPO compared with other acne treatments.
Conclusions: Tret-BPO is a safe and effective novel therapy for acne vulgaris. Poor adherence is a major hurdle in management; the combination of two separate first-line drugs may address this hurdle by decreasing the complexity of treatment regimens. J Drugs Dermatol. 2022;21(10):1098-1103. doi:10.36849/JDD.6808.