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OpenTrials
Completed

NCT Number: NCT04275999

Rosacea and Ivermectin

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest Health Sciences Dermatology

Winston-Salem, North Carolina, 27104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: digital interaction survey with ivermectin

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.

Other names: GPSkin Barrier®

Primary outcomes

  1. Adherence - MEMs Cap

    Time frame: Month 3

    Electronic monitoring of the ivermectin

  2. Adherence - Drug Weight

    Time frame: Baseline

    the ivermectin will be weighed

  3. Adherence - Drug Weight Change

    Time frame: Change from baseline to Month 3

    the ivermectin will be weighed

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Feb 19, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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