Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included.
详细描述
A randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses and pruritus change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-18 years old
- •mild to moderate atopic dermatitis
- •an IGA score of 2-3
- •BSA score of 1%-10%.
排除标准
- •participation in any clinical trial less than 28 days before the enrollment
- •AD-related systemic therapy or phototherapy within 28 days prior to the enrollment
- •topical corticosteroids, calcineurin inhibitors, or PDE4 inhibitors use within 7 days prior to the enrollment
研究组 & 干预措施
Medihoney Derma Cream
Intervention group: Medihoney Derma Cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial.
干预措施: Medihoney Derma Cream (Drug)
Hydrocortisone 1% cream
control group: Hydrocortisone 1% cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial.
干预措施: Hydrocortisone 1% cream (Drug)
结局指标
主要结局
response rate
时间窗: 1 month
This study's primary outcome was defined as an IGA (Investigator Global Assessment) severity score of 0 or 1 with at least 1-grade reduction at visit 3. score range 0-4 (4 worse symptomes)
次要结局
- The Eczema Area and Severity Index (EASI)(2 weeks)
- SCORAD - (SCORing Atopic Dermatitis)(2 weeks)
- VAS (Visual Analogue Scale) pruritis score(1 month)
研究者
AMIR HOREV
Head of pediatric dermatology
Soroka University Medical Center