A Clinical Trial to Determine the Therapeutic Benefit of an Investigational Over-The-Counter Cream on Dry, Itchy Skin of Adults and Children With Atopic Dermatitis.

Johnson & Johnson Consumer Inc. (J&JCI)2 个研究点分布在 1 个国家目标入组 53 人开始时间: 2016年2月最近更新: 2017年3月6日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 53
试验地点: 2
主要终点: Change From Baseline in the Itch Assessment Score 4 Hours After Treatment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

详细描述

Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control).

Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas.

Subjects will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also be tested.

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: 是

入选标准

•Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
•Male or female of any race or ethnicity, ages 12 and older
•Diagnosed as having eczema
•Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study

排除标准

•Known sensitivity to any investigational product ingredient
•Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study
•Individuals with a history of skin cancer
•Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
•Participation in any clinical study within 30 days of Visit 1
•Active infection of any type at the start of the study
•Diagnosed as having severe eczema
•Has a compromised immune system
•Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
•Requires greater than 2.0mg/day inhaled or intranasal corticosteroids

研究组 & 干预措施

Positive Control

Active Comparator

Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin.

干预措施: EpiCeram Skin Barrier Emulsion (Device)

Experimental

Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.

干预措施: Experimental Product 1% Colloidal Oatmeal Balm (Drug)