Dear editor
We read the review by Sanchez et alCitation1 that summarizes the clinical data evaluating clascoterone cream 1% for acne vulgaris treatment. We identified several data errors and numerous inaccuracies in how the literature was cited within their article that require correction. We would like to highlight the most significant errors. In the Phase 2a study, the percentage of patients with abnormal hypothalamic pituitary adrenal axis suppression was 7% (3 of 42 patients) and not 42.7% as stated in the review.Citation2 Further, the study had an open-label design and was not a randomized controlled trial.Citation2 The authors also incorrectly reported the percentages of males and females enrolled in the study and mean maximum clascoterone concentrations in plasma; 36% (15 of 42) of patients were male and 64% (27 of 42) were female, and the mean maximum clascoterone concentrations in plasma were 4.4 ng/mL (Cohort 1) and 4.6 ng/mL (Cohort 2).Citation2
When describing the Phase 2b dose-escalating study,Citation3 authors accurately report the number of individuals experiencing at least 1 adverse event (AE) for those who received vehicle and clascoterone 0.1% twice daily, but then reported the number of patients with more than 1 AE for the clascoterone 1.0% twice daily group. Further, the percentage of patients with mild erythema was 36.8% and not 32.6%.Citation3 In Table 1 of the review, the median change in inflammatory lesion count (ILC) is reported as 13.5, but it should be −13.5.Citation3 The minus sign appears to have remained on the previous line rather than with the value.
Errors also exist in the summary of Phase 3 data.Citation4,Citation5 In Table 1 of the review, the authors only report data from one of the two Phase 3 pivotal trials. The data from both should be reported. The text in this column should start with “in the two studies” rather than “in two of the sites.” Further, the correct P-value for ILC reductions with clascoterone cream 1% vs vehicle was 0.003,Citation5 not P <0.001. Additionally, the authors report that “18% of 347 subjects” developed treatment-emergent AEs in the open-label extension study, but the denominator should be 607 patients (safety population) and not 347.Citation4 The authors also state that nasopharyngitis occurred in 20 of 179 patients, whereas 20 events were reported in 16 of 607 patients in the cited source.Citation4
Given the number and seriousness of these errors, we strongly request that the authors address them and provide a corrected version of the article.
Disclosure
AM is employed as the chief medical officer for Cassiopea S.p.A., and holds stock options in the company, and has served as the chief medical officer of Cosmo Pharmaceuticals. KK is an employee of Sun Pharmaceutical Industries, Inc. LM served as CSO of Cassiopea S.p.A. The authors report no other conflicts in this communication.
Acknowledgments
Medical writing and editorial support were provided by Dana Lengel, PhD, of AlphaBioCom, a Red Nucleus company, and funded by Sun Pharma.
References
- Sanchez C, Keri J. Androgen receptor inhibitors in the treatment of acne vulgaris: efficacy and safety profiles of clascoterone 1% cream. Clin Cosmet Investig Dermatol. 2022;15:1357–1366. doi:10.2147/CCID.S289750
- Mazzetti A, Moro L, Gerloni M, Cartwright M. Pharmacokinetic profile, safety, and tolerability of clascoterone (cortexolone 17-alpha propionate, CB-03-01) topical cream, 1% in subjects with acne vulgaris: an open-label phase 2a study. J Drugs Dermatol. 2019;18(6):563.
- Mazzetti A, Moro L, Gerloni M, Cartwright M. A phase 2b, randomized, double-blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial acne. J Drugs Dermatol. 2019;18(6):570.
- Eichenfield L, Hebert A, Gold LS, et al. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol. 2020;83(2):477–485. doi:10.1016/j.jaad.2020.04.087
- Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(6):621–630. doi:10.1001/jamadermatol.2020.0465