Improvement of Atopic Dermatitis Symptoms and Signs by Jelly Fig (Ficus Awkeotsang Makino) Extract
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High-dose FAE cream (5.0 mg/mL)
Ficus awkeotsang Makino extract (FAE)
干预措施: FAE cream (Drug)
Low- dose FAE cream (1.0 mg/mL)
Ficus awkeotsang Makino extract (FAE)
干预措施: FAE cream (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success
时间窗: 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 (%)
次要结局
- 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)
研究者
Chiau-Sheng Jang
Department of Dermatology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
Kaohsiung Veterans General Hospital.