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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose FAE cream (5.0 mg/mL) | Active Comparator | Ficus awkeotsang Makino extract (FAE) |
|
| Low- dose FAE cream (1.0 mg/mL) | Active Comparator | Ficus awkeotsang Makino extract (FAE) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAE cream | Drug | Ficus awkeotsang Makino extract (FAE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 7, and Day 28 |
| Change in Peak Pruritus Numerical Rating Scale (pp-NRS) Score from Baseline to Days 7 and 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | Kaohsiung | 813414 | Taiwan |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Drug | Placebo |
|
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 |
| 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 (%) | Baseline, Day 7, and Day 28 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |