The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Topical Gel
Principal Investigator
Philadelphia, Pennsylvania, United States
RECRUITINGPercent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)
Time frame: 29 days
Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of "Clear" (0) or "Almost Clear" (1) with a minimum 2-grade improvement at Day 29
Time frame: 29 Days
Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29
Time frame: 29 Days
Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29
Time frame: 29 Days
Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29
Time frame: 29 Days
Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD
Time frame: 29 Days
Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)
Time frame: 29 Days
Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)
Time frame: 29 Days
Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale
Time frame: 29 days
Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)
Time frame: 29 days
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Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29
Time frame: 29 Days