Skip to main content
OpenTrials
Completed

NCT Number: NCT07113366

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, 813414, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAE cream

Drug

Ficus awkeotsang Makino extract (FAE)

Placebo

Drug

Placebo

Primary outcomes

  1. Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: Baseline, Day 7, and Day 28

    This outcome measures the percentage of body surface area affected by atopic dermatitis.

    Unit of Measure: Percent (%)

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Improvement of Atopic Dermatitis Symptoms and Signs by Jelly Fig (Ficus Awkeotsang Makino) Extract

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.