Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris

January 2024 | Volume 23 | Issue 1 | 1278 | Copyright © January 2024


Published online December 12, 2023

Lawrence F. Eichenfield MDa, Linda Stein Gold MDb, Jenny Han MSc, Adelaide A. Hebert MDd, Alessandro Mazzetti MDe, Luigi Moro PhDe, Nicholas Squittieri MDf, Diane Thiboutot MDg

aDepartments of Dermatology and Pediatrics, University of California San Diego and Rady Children’s Hospital-San Diego, San Diego, CA
bDepartment of Dermatology, Henry Ford Medical Center, Detroit, MI
cPharmapace, Inc., San Diego, CA
dDepartment of Dermatology, UTHealth McGovern Medical School, Houston, TX
eCassiopea S.P.A., Lainate, Italy
fSun Pharmaceutical Industries, Inc., Princeton, NJ 
gDepartment of Dermatology, The Pennsylvania State University College of Medicine, Hershey, PA

DISCUSSION

The present post hoc analysis was performed to assess the integrated efficacy of clascoterone in patients aged 12 years or older with moderate-to-severe facial and/or truncal acne vulgaris in the ITT populations across the pivotal and extension studies. The proportion of clascoterone-treated patients with facial IGA of 0/1 became significant at week 12 and continued to increase throughout the LTE study; the reductions in NILC, ILC, and TLC also reached significance at weeks 8 or 12. Efficacy also increased over time for patients reassigned from vehicle to clascoterone treatment and those who were treated for truncal acne.

Results from the current analysis align with the previously published results on the efficacy of clascoterone in patients with acne vulgaris.3,8,9 This study expands the efficacy analyses to include time points before week 12 in the pivotal studies and the entire ITT population rather than the per-protocol population in the LTE study, allowing a comparison of success rates in the pivotal and extension studies. Although substantial numbers of patients did not complete the LTE study, as expected in a study of this duration, efficacy in the ITT population increased over time during treatment.

This analysis has some limitations. First, there was a high patient discontinuation rate before and during the LTE study, a common problem in studies with long-term follow-up. Therefore, the results of patients who entered and remained in the extension study may not be generalizable to the entire study population, which may further limit generalizability from the clinical studies to real-world patients. Second, the effect of clascoterone treatment on patients' quality of life was not assessed. Third, the majority of patients in the clinical trials were White (greater than 84%) and not of Hispanic or Latino origin (greater than 74%). Future studies should investigate the efficacy of clascoterone in a more diverse patient population.

CONCLUSION

The efficacy of clascoterone cream 1% for the treatment of acne vulgaris increased over time for up to 12 months in all treated patients aged 12 years or older with acne vulgaris. Clinicians may consider counseling patients that treatment persistence is required to maximize the efficacy of clascoterone treatment.

DISCLOSURES

LFE, AAH, and LSG were study investigators. LFE, AAH, and LSG were also compensated advisors to Cassiopea S.p.A. AAH is an employee of the McGovern Medical School of The University of Texas Health Science Center in Houston, Texas, which received compensation from Cassiopea S.p.A. for study participation; she also received an honorarium for serving on the Cassiopea advisory board; all research grant funds were paid to her institution. She also received personal fees for advisory, speaking, and consulting roles from Pfizer, Sun Pharma, 

Galderma, Arcutis, Incyte, and LEO Pharma. LFE is an employee of the University of California San Diego, which received compensation from Cassiopea S.p.A. for study participation; he also served as an investigator, advisor, or consultant for Almirall, Dermata, Galderma Laboratories, Ortho Dermatologics, and Pfizer. LSG is an employee of the Henry Ford Health System in Detroit, Michigan, which received compensation from Cassiopea S.p.A. for study participation; she also received personal fees for advisory, speaking, consulting, research, and/or other services from Almirall, Foamix, Galderma Laboratories, Novartis, Sol-Gel, and Sun Pharma. JH is an employee of Pharmapace, Inc. 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. LM is an employee of Cassiopea S.p.A. and holds stock options in the company. NS is an employee of Sun Pharmaceutical Industries, Inc. DT served in the past as a consultant to Cassiopea, Inc., and is an employee of the College of Medicine at The Pennsylvania State University in Hershey, which received compensation from Cassiopea S.p.A. for study participation; she also received honoraria from Galderma Laboratories and Novartis.

ACKNOWLEDGMENT

The authors thank the patients, investigators, and sites for their participation. The studies were funded by Cassiopea S.p.A. Medical writing, and editorial support was provided by Nitish Chaudhari, PhD, of AlphaBioCom, a Red Nucleus company, and funded by Sun Pharma.

REFERENCES

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  2. Lynn DD, Umari T, Dunnick CA, Dellavalle RP. The epidemiology of acne vulgaris in late adolescence. Adolesc Health Med Ther. 2016;7:13. 
  3. Hebert A, Thiboutot D, Gold LS, 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.
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  6. WINLEVI® (clascoterone cream 1%) [package insert]. Sun Pharmaceutical Industries, Inc.; 2022.
  7. 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.
  8. Eichenfield L, Hebert A, Gold LS, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients 12 years of age or older with acne vulgaris. 2023. Accepted.
  9. Hebert A, Eichenfield L, Thiboutot D, et al. Efficacy and safety of 1% clascoterone cream in patients aged 12 years or older with acne vulgaris. J Drugs Dermatol. 2023;22(2):174-181.

AUTHOR CORRESPONDENCE

Lawrence F. Eichenfield MD leichenfield@rchsd.org
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