Efficacy
the WINLEVI® Way

Models shown are not actual patients.

Winlevi provides you with another option in your treatment approach

Treatment Success: IGA

Treatment success at week 121,2

Twice-daily WINLEVI (clascoterone) cream 1% monotherapy resulted in the following:

Significantly increased investigator's global assessment (IGA) treatment success2*

WINLEVI® (clascoterone cream 1%) Treatment Success at 12 Weeks vs Vehicle Chart

Treatment success criteria

*Stringent 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).1

STUDY DESIGN: In 2 identical, randomized, double-blind, vehicle controlled trials with a total of 1421 enrolled subjects 12 years of age and older with facial acne vulgaris, WINLEVI was statistically superior over vehicle for all 3 coprimary endpoints,3 including IGA success* and absolute change from baseline in inflammatory and noninflammatory lesion counts.1 Mean percent change from baseline in total, inflammatory, and noninflammatory lesion counts, and absolute change from baseline in total lesion counts were secondary endpoints. Data shown are pooled efficacy results for patients ages 12 and older.

Treatment success long-term2,4*

A summary of secondary efficacy endpoints in a phase 3, open-label, long-term, 9-month extension study2,4*

Investigator's global assessment (IGA) scores of 0 or 1 over time

WINLEVI® (clascoterone cream 1%) Long-Term Treatment Success Chart

Treatment success criteria

*Stringent 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).1

Study was not designed to assess efficacy, and long-term efficacy was not a primary endpoint. Primary endpoints in this safety study were adverse events (AEs) and serious AEs.4

STUDY DESIGN: Patients who had completed one of the WINLEVI 12-week randomized, placebo-controlled phase 3 pivotal trials for facial acne were eligible to continue with WINLEVI in the open-label, single arm, long-term extension study. Study subjects (n=607) applied WINLEVI 2X daily for up to 9 months on the face, trunk, or both.2,4 Mean overall daily WINLEVI exposure: 2.3 g (range, 0.2 g to 13 g).2,4

Patients off treatment for more than 3 days were not eligible.

End of 12-month study; N=347. Clascoterone (n=179); vehicle (n=168).

Focus on before-and-after results

See the difference for patients on twice-daily WINLEVI (clascoterone) cream 1% monotherapy at week 121

Most common adverse reactions occurring in 7% to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.

WINLEVI® (clascoterone cream 1%) Before and After Results Day 1 vs Week 12 Patient 1

Actual female patient from Winlevi clinical trial

A different way to treat acne    •

Treatment Success: Lesion Count

Treatment success at week 121,2

Twice-daily WINLEVI (clascoterone) cream 1% monotherapy resulted in the following:

Inflammatory lesion count: mean percent change

Mean Percent Change in Inflammatory Lesion Count at Week 12

STUDY DESIGN: In 2 identical, randomized, double-blind, vehicle controlled trials with a total of 1421 enrolled subjects 12 years of age and older with facial acne vulgaris, WINLEVI was statistically superior over vehicle for all 3 coprimary endpoints,3 including IGA success and absolute change from baseline in inflammatory and noninflammatory lesion counts.1 Mean percent change from baseline in total, inflammatory, and noninflammatory lesion counts, and absolute change from baseline in total lesion counts were secondary endpoints. Data shown are pooled efficacy results for patients ages 12 and older.

Treatment success at week 121,2

Twice-daily WINLEVI (clascoterone) cream 1% monotherapy resulted in the following:

Noninflammatory lesion count: mean percent change

Mean Percent Change in Non-Inflammatory Lesion Count at Week 12

STUDY DESIGN: In 2 identical, randomized, double-blind, vehicle controlled trials with a total of 1421 enrolled subjects 12 years of age and older with facial acne vulgaris, WINLEVI was statistically superior over vehicle for all 3 coprimary endpoints,3 including IGA success and absolute change from baseline in inflammatory and noninflammatory lesion counts.1 Mean percent change from baseline in total, inflammatory, and noninflammatory lesion counts, and absolute change from baseline in total lesion counts were secondary endpoints. Data shown are pooled efficacy results for patients ages 12 and older.

Focus on before-and-after results

See the difference for patients on twice-daily WINLEVI (clascoterone) cream 1% monotherapy at week 121

Most common adverse reactions occurring in 7% to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.

WINLEVI® (clascoterone cream 1%) Before and After Results Day 1 vs Week 12 Patient 1

Actual male patient from Winlevi clinical trial

Dosing and Safety the WINLEVI Way

Models shown are not actual patients.

WINLEVI: Twice daily for female AND male patients 12 years and older.1

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