Transepidermal Water Loss (TEWL) and Corneometry With Hydrogel Vehicle in the Treatment of Atopic Dermatitis - A Randomized, Investigator-Blind Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion
研究概览
简要总结
While the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in maintaining the epidermal barrier in subjects with atopic dermatitis.
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
- Single (Investigator)
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
- •Definitive diagnosis of atopic dermatitis as characterized by Hanifin and Rajka criteria:
- •3 out of 4 major characteristics
- •At least 3 minor characteristics
- •Mild to moderate disease score of 2 or 3 by Investigator Global Assessment
- •Minimum 5% Body Surface Area at Baseline
- •Uniformly bilateral signs and symptoms of atopic dermatitis
- •Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must also have written informed consent of the parent or legal guardian.
排除标准
- •Allergy or sensitivity to any component of the test articles.
- •Subjects who have not complied with the proper washout periods for prohibited medications.
- •Significant coagulation disorder or any medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the study.
- •Recent alcohol or drug abuse is evident.
- •History of poor cooperation, non-compliance with medical treatment or unreliability
- •Participation in an investigational drug study within 30 days of the Baseline Visit.
研究组 & 干预措施
Hydrogel vehicle
Parallel designed study. Split body treatment
干预措施: Hydrogel vehicle (Drug)
Eucerin Lotion
Parallel study design. Split body study.
干预措施: Eucerin Lotion (Drug)
结局指标
主要结局
Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion
时间窗: Day 1 to Day 14
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion
Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle
时间窗: Day 1 to Day 14
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle
次要结局
- Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body(Baseline to 14 days)
- Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.(Baseline to 14 days)
研究者
Leon Kircik, M.D.
Principal Investigator
Derm Research, PLLC