Rosacea and Ivermectin

Study Overview
=================
Brief Summary
-----------------
The primary hypothesis is that weekly digital interactions and routine measurement of TEWL rates and SC 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Rosacea Following Application of Ivermectin

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: ivermectin
* Behavioral: digital interaction
* Device: GPSkin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 the subject'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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>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. | Drug: ivermectin<br>* Subjects will be given the ivermectin with an electronic monitoring device attached with a return appointment at month 3 for end of study visit. Subjects will be instructed to use the ivermectin once daily.<br>|
| Experimental: Digital Interaction Group<br>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. | Drug: ivermectin<br>* Subjects will be given the ivermectin with an electronic monitoring device attached with a return appointment at month 3 for end of study visit. Subjects will be instructed to use the ivermectin once daily.<br>Behavioral: digital interaction<br>* Subjects will receive weekly digital interaction; an electronic survey asking about their use of the ivermectin which will have the electronic monitoring device attached. Subjects will be instructed to use the ivermectin once daily. They will have a 3 month return appointment for end of study visit.<br>* Other names: digital interaction survey with ivermectin;|
| Experimental: GPSkin group<br>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. | Drug: ivermectin<br>* Subjects will be given the ivermectin with an electronic monitoring device attached with a return appointment at month 3 for end of study visit. Subjects will be instructed to use the ivermectin once daily.<br>Device: GPSkin<br>* 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 with the electronic monitoring device once daily. They will be scheduled for a 3 month end of study visit.<br>* Other names: GPSkin Barrier®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence - MEMs Cap | Electronic monitoring of the ivermectin | Month 3 | 
| Adherence - Drug Weight | the ivermectin will be weighed | Baseline | 
| Adherence - Drug Weight Change | the ivermectin will be weighed | Change from baseline to Month 3 | 
| Transepidermal water loss (TEWL) rates | Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates | Baseline | 
| Transepidermal water loss (TEWL) rates | Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates | Change from baseline to 3 months | 
| Level of stratum corneum (SC) hydration | Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates | Baseline | 
| Level of stratum corneum (SC) hydration. | Use of the GPSkin Barrier device a or a portable hydration measurement device that measures TEWL rates | Change from baseline to 3 month |