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

NCT07113366 | Completed Phase 1

• 1 other identifier: KSVGH24-CT3-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Eczema Area and Severity Index (EASI) Score from Baseline to Days 7 and 28

  Baseline, Day 7, and Day 28

• Change in Peak Pruritus Numerical Rating Scale (pp-NRS) Score from Baseline to Days 7 and 28

  Baseline, Day 7, and Day 28

• Change in Body Surface Area (BSA) Affected by Atopic Dermatitis from Baseline to Days 7 and 28

  Baseline, Day 7, and Day 28

Study Arms (3)

High-dose FAE cream (5.0 mg/mL)

ACTIVE COMPARATOR

Ficus awkeotsang Makino extract (FAE)

Drug: FAE cream

Low- dose FAE cream (1.0 mg/mL)

ACTIVE COMPARATOR

Ficus awkeotsang Makino extract (FAE)

Drug: FAE cream

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

FAE cream DRUG

Ficus awkeotsang Makino extract (FAE)

High-dose FAE cream (5.0 mg/mL); Low- dose FAE cream (1.0 mg/mL)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, 813414, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Dermatology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 8, 2025
• Study Start: May 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: November 30, 2024
• Last Updated: August 8, 2025

Record last verified: 2024-05

Locations

TW (1)