Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Rosacea Following Application of Ivermectin
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
- Adherence - MEMs Cap
研究概览
简要总结
The primary hypothesis is that weekly digital interactions and routine measurement of Transepidermal Water Loss (TEWL) rates and Subcutaneous hydration levels will promote patient adherence to maintenance ivermectin therapy and prevent disease relapse. The project will consist of a trial in which thirty subjects with rosacea receive ivermectin therapy and are randomized to receive either no intervention, a weekly digital survey to assess patient's attitudes towards ivermectin therapy, or a portal hydration measurement device that measures TEWL rates and SC hydration levels. The study team will measure adherence objectively in all groups with electronic monitors attached to the containers of the ivermectin, which all subjects will be told to use daily for maintenance therapy. Additionally, the hydration measurement device can transmit data to an Internet server via a smartphone using Bluetooth technology, thereby allowing providers to monitor a patient's TEWL rate and SC levels.
详细描述
Subjects will be offered an opportunity to participate in the study. Subjects will either have a diagnosis of rosacea. A total of 30 subjects will be enrolled. After consent and basic demographics, a study team member will use the GPSkin Barrier® to measure the baseline moisture level of the face of all subjects. Subjects will also fill out questionnaires pertaining to quality of life, accountability, and severity of rosacea.
Subjects will be randomized into one of three arms: the control group (n= 10), the digital interaction group (n=10), or the GPSkin group (n=10). All subjects will receive ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea. The digital interaction group will receive a survey by email each week asking about their use ivermectin generated by Causa Research. The subjects in the GPSkin group will receive the GPSkin Barrier® to measure their moisture level of their face daily. Subjects will be instructed to use the ivermectin once daily. Subjects will return at 3 Months. At this visit, the data from the electronic adherence monitoring will be downloaded, the ivermectin will be weighed, and the subject will fill out the same questionnaires (quality of life, accountability, and severity of rosacea). The intervention subjects will be evaluated on their use of the GPSkin Barrier® to measure their stratum corneum hydration. Subjects not randomized to the email intervention group will receive an accountability questionnaire at the beginning and end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or older.
- •Subject has a working knowledge of English.
- •Subject with a diagnosis of Rosacea
- •Subjects without a known allergy to ivermectin
- •Subjects with access to a smart phone
排除标准
- •Subjects under 18 years of age.
- •Subject does not have a working knowledge of English.
- •Subject with a diagnosed skin condition other than rosacea
- •Subjects with a known allergy to ivermectin
- •Subjects without access to a smart phone
研究组 & 干预措施
Control Group
In the control group, all subjects will receive ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea. Subjects will not receive any follow-up intervention from the study team.
干预措施: ivermectin (Drug)
Digital Interaction Group
The digital interaction group will receive a survey by email each week asking about their use ivermectin generated by Causa Research; in addition to receiving ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea.
干预措施: ivermectin (Drug)
Digital Interaction Group
The digital interaction group will receive a survey by email each week asking about their use ivermectin generated by Causa Research; in addition to receiving ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea.
干预措施: digital interaction (Behavioral)
GPSkin group
The GPSkin group will receive the GPSkin Barrier® to measure their moisture level of their face daily. Subjects will be instructed to use the ivermectin once daily. Subjects also are receiving the ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea.
干预措施: ivermectin (Drug)
GPSkin group
The GPSkin group will receive the GPSkin Barrier® to measure their moisture level of their face daily. Subjects will be instructed to use the ivermectin once daily. Subjects also are receiving the ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea.
干预措施: GPSkin (Device)
结局指标
主要结局
Adherence - MEMs Cap
时间窗: Month 3
Electronic monitoring of the ivermectin
Adherence - Drug Weight
时间窗: Baseline
the ivermectin will be weighed
Adherence - Drug Weight Change
时间窗: Change from baseline to Month 3
the ivermectin will be weighed
Level of stratum corneum (SC) hydration
时间窗: Baseline
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Transepidermal water loss (TEWL) rates
时间窗: Change from baseline to 3 months
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Level of stratum corneum (SC) hydration.
时间窗: Change from baseline to 3 month
Use of the GPSkin Barrier device a or a portable hydration measurement device that measures TEWL rates
次要结局
未报告次要终点