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INDICATION AND IMPORTANT SAFETY INFORMATION

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EFFICACY

THE
WINLEVI ®
WAY
Hypothetical Female WINLEVI® (clascoterone cream 1%) Patient

FOCUS ON BEFORE-AND-AFTER RESULTS

See the difference for patients at week 12 on twice-daily WINLEVI (clascoterone) cream 1% monotherapy1

MALE

WINLEVI® (clascoterone cream 1%) Results After 12 Weeks in Male Patient
WINLEVI® (clascoterone cream 1%) Results After 12 Weeks in Male Patient

ACTUAL PATIENT PHOTOS FROM WINLEVI CLINICAL TRIALS

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.

FEMALE

WINLEVI® (clascoterone cream 1%) Results After 12 Weeks in Female Patient
WINLEVI® (clascoterone cream 1%) Results After 12 Weeks in Female Patient

ACTUAL PATIENT PHOTOS FROM WINLEVI CLINICAL TRIALS

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.

TREATMENT SUCCESS: IGA

Treatment success at week 121,2

Twice-daily WINLEVI (clascoterone) cream 1% monotherapy

Significantly Increased Investigator’s Global Assessment (IGA) Treatment Success1-3

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 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

Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.

Long-term treatment success in facial and trunk acne

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

*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. 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).

A UNIQUE WAY TO TOPICALLY 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 CHANGE2

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.

Inflammatory lesion count mean absolute change

In clinical studies, when used twice daily as a monotherapy, at week 12 WINLEVI was statistically more effective than vehicle with a mean absolute reduction in inflammatory lesion count of 19.7 vs 14.0 (P<0.0001).2

Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.

Treatment success at week 121,2

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

NONINFLAMMATORY LESION COUNT: MEAN PERCENT CHANGE2

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.

Noninflammatory lesion count mean absolute change

In clinical studies, when used twice daily as a monotherapy, at week 12 WINLEVI was statistically more effective than vehicle with a mean absolute reduction in noninflammatory lesion count of 20.8 vs 11.9 (P<0.0001).2

Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.

Treatment success at week 121,2

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

TOTAL LESION COUNT: MEAN PERCENT CHANGE2

Mean Percent Change in Total 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.

Total lesion count mean absolute change

In clinical studies, when used twice daily as a monotherapy, at week 12 WINLEVI was statistically more effective than vehicle with a mean absolute reduction in total lesion count of 40.0 vs 26.1 (P<0.0001).2

Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.

WINLEVI® (clascoterone) cream 1% Prescription Tube
IN CLINICAL TRIALS

12-WEEK TREATMENT SUCCESS

WAS BASED ON TWICE-DAILY DOSING WITH WINLEVI.1
LEARN MORE ABOUT TWICE-DAILY DOSING