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

Kaohsiung Veterans General Hospital

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: FAE cream; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07113366

KSVGH24-CT3-31

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 3 patient groups, including a placebo group

High-dose FAE cream (5.0 mg/mL)

Active Comparator group

Description:

Ficus awkeotsang Makino extract (FAE)

Treatment:

Drug: FAE cream

Low- dose FAE cream (1.0 mg/mL)

Active Comparator group

Description:

Ficus awkeotsang Makino extract (FAE)

Treatment:

Drug: FAE cream

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo