Clinical evidence

Proven Efficacy, Consistent across trials

WINLEVI® was studied in 2 identical phase III pivotal trials and was statistically superior over vehicle for all coprimary endpoints.2

PHASE III EFFICACY: STUDY DESIGN

WINLEVI® WAS ASSESSED IN TWO IDENTICALLY-DESIGNED PHASE III, MULTICENTRED, RANDOMISED, DOUBLE-BLIND, VEHICLE-CONTROLLED CLINICAL TRIALS ENROLLING IN TOTAL 1440 SUBJECTS WITH FACIAL ACNE VULGARIS.2

EFFICACY WAS ASSESSED AT WEEK 12 BY THE PROPORTION OF SUBJECTS IN EACH TREATMENT GROUP WITH:2

  • At least a 2-point reduction in IGA compared to baseline and an IGA score of 0 (clear) or 1 (almost clear)
  • Absolute change and % change from baseline in NILC and ILC

SECONDARY EFFICACY ENDPOINTS INCLUDED:

  • Absolute and % change from baseline in TLC14
  • Subjects were 9 years or older with IGA of moderate or severe facial acne vulgaris (score of 3 or 4), 30 to 75 inflammatory lesions (papules, pustules and nodules), and 30 to 100 non-inflammatory lesions (open and closed comedones).2
  • Patient baseline demographic and clinical characteristics were generally balanced between treatment arms.14
  • Of these 1 440 randomised subjects, 19 (1.3%) were 9 to 11 years of age, 641 (44.5%) were 12 to 17 years of age, and 780 (54.2%) were 18 years of age or older. Among adults and adolescents, 62% of the subjects were female and 91% were Caucasian. At baseline, subjects had a mean ILC of 42.4 and a mean NICL of 61.4. Approximately 83% of subjects had an IGA score of 3.2

IGA, Investigator’s Global Assesment; ILC, inflammatory lesion count; NILC, noniflammatory lesion count; TLC, total lesion count.

PROVEN EFFICACY, CONSISTENT ACROSS TRIALS

  • WINLEVI® is efficacious in reducing acne lesions when compared to vehicle.2,a
  • Findings have been consistent across two separate trials.2
  • WINLEVI® was studied in 2 identical phase Ill pivotal trials and was statistically superior over vehicle for all coprimary endpoints.2 Systemic side effects were noted in the phase III trials 25 and 26.2

SIGNIFICANTLY INCREASED
IGA TREATMENT SUCCESS2,b

a The vehicle cream was identical to clascoterone 10 mg/g cream, in terms of colour, consistency, and smell, and the creams were packed in identical blinded tubes.14 The difference between placebo and vehicle is that the vehicle is equivalent to active drug, minus the active component. Thus, vehicle contains only relatively inert substances, while a placebo is intended to have no pharmacological activity. 15

b IGA success was defined as at least a 2-point reduction in IGA score from baseline and an IGA score of 0 (clear) or 1 (almost clear).2

CI, confidence interval; IGA, Investigator’s Global Assesment.

OUTCOME MEASURES ACROSS BOTH PHASE III TRIALS

Main outcomes and measures

Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline and absolute change from baseline in NILC and ILC counts at week 12.14

Safety measures included adverse event frequency and severity.14

(adapted from Hebert et al. 202016)

IGA, Investigator’s Global Assesment; ILC, inflammatory lesion count; NILC, noniflammatory lesion count.

EFFICACY (CO-PRIMARY ENDPOINTS) ITT (WEEK 12)

a Adjusted proportion of patients with treatment success defined as at least 2-point reduction in IGA vs baseline and an IGA score of 0 or 1 at week 12.

CI, confidence interval; IGA, Investigator Global Assessment; ITT, intention to treat.

PRIMARY ENDPOINT EFFICACY

CLINICAL EFFICACY OF CLASCOTERONE CREAM IN SUBJECTS WITH ACNE VULGARIS AT WEEK 12

For the 3 primary endpoints, proportion of subjects aged ≥12 years achieving “success” at week 12, absolute change from baseline in NILC at week 12, and absolute change from baseline in ILC at week 12, the results were similar between the 2 studies and, as expected based on the significant results in each study.2

a Investigator Global Assessment (IGA) success was defined as at least a 2-point reduction in IGA compared to baseline and an IGA score of 0 (clear) or 1 (almost clear).
CI, confidence interval; IGA, Investigator’s Global Assesment; ILC, inflammatory lesion count; NILC, noniflammatory lesion count.

SECONDARY ENDPOINT EFFICACY

Secondary efficacy end points for both studies included absolute and % change from baseline in TLC at week 12. The percentage change from baseline to week 12 was statistically significantly greater in the clascoterone group than the vehicle group for TLC.14,17

Absolute change in baseline TLC from baseline at week 1217

a LS mean and p-value are based on analysis of covariance with treatment and analysis center as fixed effects, and baseline value as a covariate.
CI, confidence interval; LS, least square; NA, not applicable; TLC, total lesion count.

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Indication

WINLEVI® (clascoterone) 10 mg/g cream is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.3

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Glenmark Pharmaceuticals Europe Ltd medical_information@glenmarkpharma.com or call 0800 458 0383.

References

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See yellowcard.mhra.gov.uk for how to report side effects.

 

  1. Kurokawa I, et al. Dermatol Ther (Heidelb). 2021;11(4):1129-1139.
  2. Tuchayi S, et al. Acne vulgaris. Nat Rev Dis Primers. 2015; 1:15029.
  3. WINLEVI® SPC
  4. Piszczatoski CR, Powell J. Clin Ther. 2021;43(10):1638-1644.
  5. Rosette C, et al. J Drugs Dermatol. 2019;18(5):412-418.
  6. Eichenfield LF, et al. J Drugs Dermatol. 2024;23(1):1278-1283.
  7. Purdy S, DeBerker D. BMJ Clin Evid. 2008;1714.
  8. Zouboulis CC, Bettoli V. Br J Dermatol. 2015;Suppl 1:27-36.
  9. ONS. Estimates of the population for the UK, England, Wales, Scotland and Northern Ireland. Accessed 27 June 2024. https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland.
  10. Primary Care Dermatology Society. Acne: acne vulgaris. Accessed 27 June 2024. https://www.pcds.org.uk/clinical-guidance/acne-vulgaris.
  11. Dawson AL, et al. BMJ. 2013;346:f2634.
  12. Layton AM, Thiboutot D, Tan J. Br J Dermatol. 2021;184(2):219-225.
  13. Morshed ASM, et al. Sci Rep. 2023; 13: 21084.
  14. Baldwin, H et al. J Drugs Dermatol. 2023;22(6):582-587.
  15. Del Rosso JQ, Kircik L. J Dermatolog Treat. 2024;35(1):2298878.
  16. Kim HJ, et al. Int J Mol Sci. 2024;25(10):5302.
  17. Hebert A, et al. J Drugs Dermatol. 2023;22(2):174-181.
  18. Hebert A, et al. JAMA Dermatology. 2020;156(6):621–630
  19. Abelson MB, Fink K. (2003). Controlling for the Placebo Effect. Review of Ophthalmology. Accessed 17 October 2024. https://www.reviewofophthalmology.com/article/controlling-for-the-placebo-effect.
  20. Hebert A, et al. JAMA Dermatology. 2020;156(6):621–630 (Supplement 1).
  21. Shergill M, et al. Dermatol Ther (Heidelb). 2024;14:1093–1102.
  22. Eichenfield L, et al. J Am Acad Dermatol. 2020;83(2):477-485.
  23. Mazzetti A, et al. J Drugs Dermatol. 2019;18(6):563.
  24. NICE Clinical Knowledge Summary WINLEVI®

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