Efficacy of Jelly Fig (Ficus Awkeotsang Makino) Extract for Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis (AD)
• Interventions: Drug: FAE cream; Drug: Placebo

• Registration Number: NCT07113366
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-11-30
• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose FAE cream (5.0 mg/mL)	FAE cream	Ficus awkeotsang Makino extract (FAE)
Placebo	Placebo	-
Low- dose FAE cream (1.0 mg/mL)	FAE cream	Ficus awkeotsang Makino extract (FAE)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (%)

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan