Real-World Adverse Events Associated with Encapsulated Benzoyl Peroxide/Tretinoin, 3%/0.1%, and Encapsulated Benzoyl Peroxide, 5.

Encapsulated benzoyl peroxide, 5%, for rosacea and a combined formulation of encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, for acne vulgaris, utilize microencapsulation, a process by which active pharmaceutical agents are enclosed in inert, permeable silica shells that provide a buffer between the drug and the skin. The silica shells allow a gradual release of the drug while also allowing combinations of active ingredients that would not otherwise be possible. This technology allows benzoyl peroxide and tretinoin to be combined in the same vehicle without risking the benzoyl peroxide-mediated oxidative destruction of tretinoin. In the current study, we queried the Galderma pharmacovigilance database to quantify and categorize adverse events associated with using these products in the USA during a 12-month period from May 2022 through April 2023. The adverse events were generally mild and restricted to local irritation, pruritus, burning sensation, and erythema. The real-world incidence and type of adverse events reported by the community for encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, and benzoyl peroxide, 5%, were consistent with the safety and tolerability findings from the phase III clinical studies of these treatments.