Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Skin Sciences, PLLC
Louisville, Kentucky, United States
The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on Investigator Global Assessment (IGA) Scale at Week 16.
The investigator will evaluate global acne severity using the Investigator Global Assessment scale, which ranges from 0 to 5, where 0 represents clear skin and 5 represents very severe acne
Time frame: Week 16
Percent of Total Lesion Reduction at Week 16 Compared to Baseline
Time frame: Week 16
Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline
Time frame: Week 16
Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline.
Time frame: Week 16
Tolerability Measures of Erythema Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" erythema at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
Tolerability Measures of Dryness Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" dryness at weeks 4,8,12 and 16.
Time frame: Week 4,8,12,16
Tolerability Measures of Peeling Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'. The information presented represents the "Percentage of participant" with "Absent or Trace" peeling at weeks 4,8,12 and 16
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Time frame: Week 4,8,12,16
Assessment of Skin Oiliness Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" oiliness at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale
The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" burning at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16
Tolerability Measures of Pruritus Based on 6-point Severity Scale
The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" Pruritus at weeks 4,8,12 and 16
Time frame: Week 4,8,12,16