scaling, and pruritus, and occurrence rates of these were low; additionally, since clascoterone does not function as a corticosteroid, no topical side effects of corticosteroids such as skin atrophy or striae were observed.5 Finally, none of the side effects associated with systemic antiandrogenic medications were observed, such as feminization or decreased libido.5,23 The proportion of patients with IGA scores of 0 or 1 also increased with time spent using clascoterone 1% cream, with 48.1% of patients meeting this criteria by the end of the study.5 As a result, clascoterone 1% cream has been found to have a favorable safety and efficacy profile for males and non-pregnant females ages 12 and up for up to 12 months of continuous use (12 weeks in phase III clinical trials and 9 months in the open-label long-term extension trial).5
Some factors regarding the safety of clascoterone remain unknown. For example, no available data exists on the use of clascoterone during pregnancy to evaluate for drug-associated risk of adverse maternal and fetal outcomes; also, no data are available on the absorption of clascoterone or its metabolites into breastmilk and subsequent effects on breastfed infants.13,21 Additionally, no drug interaction studies have been completed to evaluate how clascoterone affects other acne medications and vice versa; this could be a relevant point of concern for dermatologists because acne treatment is typically multimodal in nature.10,13,21
A systematic review found that topical clascoterone is both effective at treating acne vulgaris and safe for use.3 Specifically, the study evaluated the five randomized controlled clinical trials for clascoterone discussed thus far; baseline characteristics of 2457 study participants, efficacy outcomes, and safety outcomes were extracted from each clinical trial.3 The study concluded that there was a low risk of bias in these clinical trials, and their pooled analysis confirmed that clascoterone has a tolerably similar safety profile compared with placebo.3 Additionally, clascoterone cream was found to significantly reduce noninflammatory lesion counts and led to significantly greater improvement in IGA scores compared with placebo cream.3
Clascoterone functions as an effective, safe option to both target one of the more difficult-to-treat components of acne and treat patient populations that have previously been excluded from the use anti-androgen medications. As such, clascoterone presents an exciting opportunity for dermatologists to further optimize care for eligible acne patients.
Real-world Use of Clascoterone
Existing evidence points towards clascoterone as a novel, effective treatment for patients with acne. As the first topical anti-androgen medication ever approved for treatment of acne, clascoterone presents an exciting opportunity for treatment of patients who have been excluded from anti-androgen therapy in the past, such as men.6,9,12 Similar to other topical antiacne medications, clascoterone can also be used for acne of any severity.11
Clascoterone may be used as a monotherapy or as an adjunctive medication for patients on additional acne medications.24,25 It functions as a useful alternative to systemic anti-androgen medications as a method of controlling sebum production. Because clascoterone targets a different mechanism of action from other topical medications, it can also be synergistic when used in combination with other topical acne medications such as retinoids for treatment of both inflammatory and non-inflammatory acne lesions.4,14 Additionally, clascoterone may also be used as an alternative to antibiotics in patients who are not good candidates for oral tetracycline therapy or when concern for resistance to topical antibiotics exists.3 Clascoterone can also be used in place of tretinoin given its greater tolerability and the lower incidence of LSRs associated with its use.18 Clascoterone is not included in the AAD recommendations for acne because it received FDA approval after the most recent recommendations were released in 2016; nevertheless, it is currently included in decision-making algorithms as an option for mild papulopustular or mixed comedonal and papulopustular acne that does not respond to other medications such as topical retinoids, benzoyl peroxide, topical antibiotics, or topical dapsone.25,26
Clascoterone functions as an effective, safe option to both target one of the more difficult-to-treat components of acne and treat patient populations that have previously been excluded from the use anti-androgen medications. As such, clascoterone presents an exciting opportunity for dermatologists to further optimize care for eligible acne patients.
