Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Adherence to Locoid
研究概览
简要总结
The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.
详细描述
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.
The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.
Adherence will be measured by MEMs cap.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age.
- •Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)
- •Subjects must have >5% TBSA and <30% to be enrolled.
- •Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
排除标准
- •Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject.
- •Inability to complete all study-related visits.
- •Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
- •Requiring >130 gm of cream in a 2 week period.
- •Having facial or groin involvement of their disease.
- •Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
研究组 & 干预措施
Cream-
topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis
干预措施: hydrocortisone 17-butyrate 0.1% Cream preparation (Drug)
Ointment
topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis
干预措施: hydrocortisone 17-butyrate 0.1% Ointment preparation (Drug)
Lipocream
topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis
干预措施: hydrocortisone 17-butyrate 0.1% Lipocream preparation (Drug)
结局指标
主要结局
Adherence to Locoid
时间窗: 2 weeks
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
次要结局
未报告次要终点