Phase 2
N=30
Rosacea and Ivermectin
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT04275999 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Adherence - MEMs Cap — 21; 6; 15; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ivermectin (Drug); digital interaction (Behavioral); GPSkin (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence - MEMs Cap |
21; 6; 15; 12; 14; 13 | — |
| PRIMARY Adherence - Drug Weight |
— | — |
| PRIMARY Adherence - Drug Weight Change |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04275999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.