The study is designed to evaluate the efficacy and safety of a topical formulation containing Ficus awkeotsang Makino extract (FAE), derived from jelly fig, in participants with mild to moderate atopic dermatitis. Ficus awkeotsang is a traditional plant native to Taiwan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, Taiwan
Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success
IGA success is defined as achieving a score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline on the 5-point IGA scale. The scale ranges from 0 (clear) to 4 (severe), with lower scores indicating less disease severity. Unit of Measure: Percentage of participants (%)
Time frame: Day 28
Change in Eczema Area and Severity Index (EASI) Score from Baseline to Days 7 and 28
The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. This outcome measures the change in EASI score from baseline. Unit of Measure: Units on a scale
Time frame: Baseline, Day 7, and Day 28
Change in Peak Pruritus Numerical Rating Scale (pp-NRS) Score from Baseline to Days 7 and 28
The pp-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Participants rate their worst itch over the past 24 hours. Unit of Measure: Units on a scale
Time frame: Baseline, Day 7, and Day 28
Change in Body Surface Area (BSA) Affected by Atopic Dermatitis from Baseline to Days 7 and 28
This outcome measures the percentage of body surface area affected by atopic dermatitis. Unit of Measure: Percent (%)
Time frame: Baseline, Day 7, and Day 28
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