Abstract:Benzoyl peroxide (BPO) has been used extensively in dermatology, often for the treatment of acne vulgaris. In a 20-year period, dermatologists in the United States used over-the-counter BPO more than 13 million times. However, skin irritation and other adverse events (AEs) are associated with the use of BPO. AEs associated with BPO were identified using the Galderma pharmacovigilance system, which collects AE reports from multiple sources. Over approximately 20 years, 558 AE reports were collected from the dat… Show more
“…One limitation of this study is that we did not directly compare the AE rates of E-BPO to those of unencapsulated formulations during the same period. Instead, we drew our comparison using 29 years’ worth of over-the-counter BPO-associated AE reports and a single year of E-BPO-associated AE reports [ 15 ]. There are no prescription topical treatments available that have BPO as the sole ingredient.…”
Section: Discussionmentioning
confidence: 99%
“…They also complement results from a Galderma Global Safety Database search for AE reports associated with over-the-counter topical acne medications containing BPO from 1992 to 2021. This search produced an AE reporting rate of approximately 0.014% [ 15 ]. Fig.…”
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.
“…One limitation of this study is that we did not directly compare the AE rates of E-BPO to those of unencapsulated formulations during the same period. Instead, we drew our comparison using 29 years’ worth of over-the-counter BPO-associated AE reports and a single year of E-BPO-associated AE reports [ 15 ]. There are no prescription topical treatments available that have BPO as the sole ingredient.…”
Section: Discussionmentioning
confidence: 99%
“…They also complement results from a Galderma Global Safety Database search for AE reports associated with over-the-counter topical acne medications containing BPO from 1992 to 2021. This search produced an AE reporting rate of approximately 0.014% [ 15 ]. Fig.…”
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.
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