Atopic Dermatitis (AD)
Conditions
Brief summary
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.
Interventions
DRUGFAE cream
Ficus awkeotsang Makino extract (FAE)
DRUGPlacebo
Placebo
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥12 years at the time of enrollment * Clinical diagnosis of atopic dermatitis (AD) according to the Hanifin and Rajka criteria * Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening
Exclusion criteria
* Prior treatment with biologic agents within 16 weeks before baseline * Use of phototherapy, systemic corticosteroids, or other systemic immunosuppressants within 28 days before baseline * Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 14 days before baseline * Presence of active skin infections * Pregnancy or breastfeeding * Known hypersensitivity to any component of the investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success | Day 28 | 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 (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eczema Area and Severity Index (EASI) Score from Baseline to Days 7 and 28 | Baseline, Day 7, and Day 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 |
| Change in Peak Pruritus Numerical Rating Scale (pp-NRS) Score from Baseline to Days 7 and 28 | Baseline, Day 7, and Day 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 |
| Change in Body Surface Area (BSA) Affected by Atopic Dermatitis from Baseline to Days 7 and 28 | Baseline, Day 7, and Day 28 | This outcome measures the percentage of body surface area affected by atopic dermatitis. Unit of Measure: Percent (%) |
Countries
Taiwan
Outcome results
None listed