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

NCT ID: NCT07113366

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High-dose FAE cream (5.0 mg/mL)

Ficus awkeotsang Makino extract (FAE)

Group Type ACTIVE_COMPARATOR

FAE cream

Intervention Type DRUG

Ficus awkeotsang Makino extract (FAE)

Low- dose FAE cream (1.0 mg/mL)

Ficus awkeotsang Makino extract (FAE)

Group Type ACTIVE_COMPARATOR

FAE cream

Intervention Type DRUG

Ficus awkeotsang Makino extract (FAE)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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FAE cream

Ficus awkeotsang Makino extract (FAE)

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Chiau-Sheng Jang

Department of Dermatology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KSVGH24-CT3-31

Identifier Type: -

Identifier Source: org_study_id

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