A Double-Blind Pilot Study To Assess The Feasibility of a Larger Study to Assess The Efficacy of A Novel Gel Wash Cleanser Formulated With Sodium Hypochlorite To Reduce Skin Fauna In Patients With Chronic Hand Dermatitis/Atopic Dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Amount of Skin Fauna
研究概览
简要总结
The primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as Cetaphil Daily Facial Cleanser.
详细描述
Patients with Hand Eczema will be asked to wash with either a CLn BodyWash or Cetaphil Daily Facial Cleanser. Patients and study staff will be blinded. Hand swabs will be done prior to the wash and after 20 minutes. The average time spent in the study for each patient should be less than 2 hours unless an Adverse Event occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seen by an OSU Dermatology provider at OSU Dermatology East after the date of approval of this protocol
- •Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
- •Willingness to participate in a research study.
- •Diagnosis of chronic hand dermatitis
排除标准
- •Inability to provide informed consent
- •Allergy to any of the treatments used
研究组 & 干预措施
CLn BodyWash
CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis
干预措施: CLn BodyWash (Other)
Cetaphil Daily Facial Cleanser
Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis
干预措施: Cetaphil Daily Facial Cleanser (Other)
结局指标
主要结局
Change in Amount of Skin Fauna
时间窗: one wash
Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.
次要结局
未报告次要终点
研究者
Shari L Hand
Clinical Research Director
TopMD Skin Care, Inc.