Rosacea and Ivermectin

NCT04275999 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00062694
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Control Group

OTHER

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

Digital Interaction Group

EXPERIMENTAL

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

GPSkin group

EXPERIMENTAL

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

Interventions

digital interaction BEHAVIORAL

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

Digital Interaction Group

GPSkin DEVICE

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®

GPSkin group

ivermectin DRUG

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.

Control Group; Digital Interaction Group; GPSkin group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences Dermatology

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Research Administrative Coordinator
• Organization: Wake Forest

irma.richardson@advocatedhealth.org

3367162903

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: April 16, 2021
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)