A Phase 2 interventional study of ivermectin and digital interaction in Rosacea, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Health services research
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.
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 30 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Exclusion Criteria:
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
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 · Behavioral: digital interaction
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 · Device: GPSkin
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.
Also known as: digital interaction survey with ivermectin
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.
Also known as: GPSkin Barrier®
Adherence - MEMs Cap
Electronic monitoring of the ivermectin
Time frame: Month 3
Adherence - Drug Weight
the ivermectin will be weighed
Time frame: Baseline
Adherence - Drug Weight Change
the ivermectin will be weighed
Time frame: Change from baseline to Month 3
All enrolled participants received the same treatment - all subjects received ivermectin cream 1% to use once daily for 3 months
| Milestone | Control Group | Digital Interaction Group | GPSkin Group |
|---|---|---|---|
| Started | 0 | 30 | 0 |
| Completed | 0 | 27 | 0 |
| Not completed | 0 | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
Electronic monitoring of the ivermectin
| Participants | Control Group | Digital Interaction Group | GPSkin Group |
|---|---|---|---|
| Adherence month 1: — Adherent | — | 21 | — |
| Adherence month 1: — Non-Adherent | — | 6 | — |
| Adherence month 2: — Adherent | — | 15 | — |
| Adherence month 2: — Non-Adherent | — | 12 | — |
| Adherence month 3: — Adherent | — | 14 | — |
| Adherence month 3: — Non-Adherent | — | 13 | — |
the ivermectin will be weighed
No measurements were reported for this outcome.
the ivermectin will be weighed
No measurements were reported for this outcome.
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | — | — |
| Digital Interaction Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| GPSkin Group | — | — | — |
all subjects received ivermectin cream 1% to use once daily for 3 months - no Subjects were enrolled in the Control Group or the GPSkin Group
| Age, Categorical(Participants) | Control Group | Digital Interaction Group | GPSkin Group | Total |
|---|---|---|---|---|
| <=18 years | — | 0 | 0 | 0 |
| Between 18 and 65 years | — | 22 | 0 | 22 |
| >=65 years | — | 8 | 0 | 8 |
| Age, Continuous(years) | Control Group | Digital Interaction Group | GPSkin Group | Total |
|---|---|---|---|---|
| Mean | — | 62 (23 to 71) | — | 62 (23 to 71) |
| Sex: Female, Male(Participants) | Control Group | Digital Interaction Group | GPSkin Group | Total |
|---|---|---|---|---|
| Female | — | 21 | — | 21 |
| Male | — | 9 | — | 9 |
| Race (NIH/OMB)(Participants) | Control Group | Digital Interaction Group | GPSkin Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | — | 0 | — | 0 |
| Asian | — | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | — | 0 | — | 0 |
| Black or African American | — | 1 | — | 1 |
| White | — | 28 | — | 28 |
| More than one race | — | 1 | — | 1 |
| Unknown or Not Reported | — | 0 | — | 0 |
| Region of Enrollment(participants) | Control Group | Digital Interaction Group | GPSkin Group | Total |
|---|---|---|---|---|
| United States | — | 30 | — | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
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