Rosacea
Conditions
Brief summary
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.
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.
Interventions
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.
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.
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.
Sponsors
Study design
Intervention 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.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence - MEMs Cap | Month 3 | Electronic monitoring of the ivermectin |
| Adherence - Drug Weight | Baseline | the ivermectin will be weighed |
| Adherence - Drug Weight Change | Change from baseline to Month 3 | the ivermectin will be weighed |
Countries
United States
Contacts
Wake Forest University Health Sciences
Participant flow
Recruitment details
All enrolled participants received the same treatment - all subjects received ivermectin cream 1% to use once daily for 3 months
Pre-assignment details
subjects were only enrolled in the Digital Interaction Group - all subjects received ivermectin cream 1% to use once daily for 3 months
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 62 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 30 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 30 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 30 | 0 / 0 |