INTRODUCTION
Acne vulgaris is an inflammatory skin disorder with a global prevalence of 9.4% and 231.2 million cases reported worldwide in 2019.1 It is characterized by the presence of noninflammatory (closed or open comedones) and inflammatory (papules, pustules, nodules, and cysts) lesions.2 Although acne is most common during adolescence, it can present at any age in people of both sexes.3 Patients with acne have reduced quality of life and low self-esteem, especially those with more severe and extensive acne, adding to the high burden of disease.4
The pathogenesis of acne is driven by 4 main components: sebum production, follicular hyperkeratinization, bacterial colonization, and inflammation.2 Sebum production is largely regulated by androgens; testosterone and dihydrotestosterone bind to androgen receptors in sebocytes within the sebaceous gland, promoting the expression of genes that induce sebum production. This excess sebum leads to the accumulation of keratinocytes and colonization with Cutibacterium acnes, inducing inflammation and lesion formation.5-9
Clascoterone cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years and older.10 In two Phase 3 clinical trials (NCT02608450 and NCT02608476), clascoterone cream 1% monotherapy demonstrated superior efficacy vs vehicle for reducing acne severity and had a favorable safety and tolerability profile that was maintained for up to 9 months of treatment in an extension safety study.11-13 While the mechanism of action of clascoterone cream 1% is unknown,10 in vitro data suggest that it competes with dihydrotestosterone to bind androgen receptors and
The pathogenesis of acne is driven by 4 main components: sebum production, follicular hyperkeratinization, bacterial colonization, and inflammation.2 Sebum production is largely regulated by androgens; testosterone and dihydrotestosterone bind to androgen receptors in sebocytes within the sebaceous gland, promoting the expression of genes that induce sebum production. This excess sebum leads to the accumulation of keratinocytes and colonization with Cutibacterium acnes, inducing inflammation and lesion formation.5-9
Clascoterone cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years and older.10 In two Phase 3 clinical trials (NCT02608450 and NCT02608476), clascoterone cream 1% monotherapy demonstrated superior efficacy vs vehicle for reducing acne severity and had a favorable safety and tolerability profile that was maintained for up to 9 months of treatment in an extension safety study.11-13 While the mechanism of action of clascoterone cream 1% is unknown,10 in vitro data suggest that it competes with dihydrotestosterone to bind androgen receptors and
