INTRODUCTION
Acne is a chronic inflammatory disease of the pilosebaceous unit, affecting nearly 90% of individuals with onset occurring on or near puberty but potentially extending into adulthood.1 The American Academy of Dermatology Guidelines (AAD Guidelines) recommends first-line treatments include topical therapies, as shown in Table 1. These therapies currently include benzoyl peroxide (BPO), topical retinoids, or topical antibiotics, or a combination of these agents. If topical treatments fail to produce improvement, oral treatments are often added to the regimen, as shown in Table 2.
BPO has been one of the most important topical therapies in treating acne.2 It was the first topical therapy available over the counter and is an important, if not necessary, addition to topical and systemic antibiotic therapy to prevent multidrug resistance.3
However, in March 2024, an independent testing laboratory, Valisure Incorporated, filed a Citizen's Petition with the US Food and Drug Administration (FDA) to remove BPO from the market. Valisure, citing their testing, demonstrated in forced degradation studies that marketed BPO products can form over 800 times the FDA concentration limits of benzene including high levels at time zero in nearly half of the samples tested.4
FDA is currently reviewing the data from Valisure's Citizen Petition. If FDA determines that benzene is present as a degradant in BPO products, they may act by limiting (such as making BPO prescription only or requiring refrigerated storage) or removing any products containing BPO from the market.
After Valisure's findings, the American Acne and Rosacea Society recommended that physicians instruct patients to 1) discard expired BPO products and those exposed to temperatures above room temperature, 2) store new BPO products at refrigerated temperature, and 3) replace BPO products every 3 months.5
Current Treatments
Topical Retinoids
Topical retinoids are essentially analogues of Vitamin A that act by reducing hyperkeratinization and inflammation with once or twice-daily applications.5 Retinoids are a mainstay in the treatment of moderate-to-severe comedonal acne and are often used in combination with other topical agents. Local tolerability reactions may occur during the early course of treatment, with over 40% of patients having reported local tolerability reactions in clinical studies.6
BPO has been one of the most important topical therapies in treating acne.2 It was the first topical therapy available over the counter and is an important, if not necessary, addition to topical and systemic antibiotic therapy to prevent multidrug resistance.3
However, in March 2024, an independent testing laboratory, Valisure Incorporated, filed a Citizen's Petition with the US Food and Drug Administration (FDA) to remove BPO from the market. Valisure, citing their testing, demonstrated in forced degradation studies that marketed BPO products can form over 800 times the FDA concentration limits of benzene including high levels at time zero in nearly half of the samples tested.4
FDA is currently reviewing the data from Valisure's Citizen Petition. If FDA determines that benzene is present as a degradant in BPO products, they may act by limiting (such as making BPO prescription only or requiring refrigerated storage) or removing any products containing BPO from the market.
After Valisure's findings, the American Acne and Rosacea Society recommended that physicians instruct patients to 1) discard expired BPO products and those exposed to temperatures above room temperature, 2) store new BPO products at refrigerated temperature, and 3) replace BPO products every 3 months.5
Current Treatments
Topical Retinoids
Topical retinoids are essentially analogues of Vitamin A that act by reducing hyperkeratinization and inflammation with once or twice-daily applications.5 Retinoids are a mainstay in the treatment of moderate-to-severe comedonal acne and are often used in combination with other topical agents. Local tolerability reactions may occur during the early course of treatment, with over 40% of patients having reported local tolerability reactions in clinical studies.6
