ABSTRACT
Introduction: Acne vulgaris is a widespread skin disease. Topical therapy is a standard treatment for mild to moderate acne. Given the complex pathophysiology of acne, various agents with complementary action are nowadays frequently combined to increase the efficacy of therapy.
Area covered: This review focus on safety profile of topical agents used for the treatment of acne vulgaris, including topical retinoids, benzyl peroxide, azelaic acid, topical antibiotic, and combined agents. Data from clinical trials but also metanalyses, systematic reviews, and other secondary analyses are presented.
Expert opinion: In general, topical agents used for acne vulgaris have a favorable safety profile. The most commonly reported AEs were associated with local skin irritation, usually mild to moderate in intensity, intermittent, and rarely led to the cessation of therapy. Irritative potential seems to be highest for BPO and topical retinoids. Due to the possibility of development of Cutibacterium acnes resistance, topical antibiotics should not be used in monotherapy but as a part of combination therapy. In female adolescent and adults of childbearing potential, topical retinoids should be used with caution, because they are contraindicated in pregnant females (FDA Pregnancy category) C (adapalene, tretinoin) and X (tazarotene).
Article highlights
In general, topical agents used for AV treatment have a favorable safety profile and are not associated with systemic toxicity. The most commonly reported AEs are local skin irritations.
Irritative potential seems to be highest for BPO and topical retinoids, especially the first generation retinoids. The intensity of skin irritation depends not only on the type of active substance but also on its concentration, vehicle formulation used and mode of application.
Irritative potential of topical acne products and their tolerability are an important aspect that may affect patient adherence to the therapy in the real-world.
Topical antibiotics currently should not be used in monotherapy, but as a part of combination therapy because of C. acnes resistance.
Given the multifactorial and complex pathophysiology of AV, various agents with complementary action are nowadays frequently combined to increase efficacy and safety/tolerability of therapy and improve patient adherence. Novel-combined topical products are being currently investigated.
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Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.