INDICATION AND IMPORTANT SAFETY INFORMATION
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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.
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.
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.
*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).
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.
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.
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.
