Rosacea and Ivermectin

• Status: Active, not recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary hypothesis is that weekly digital interactions and routine measurement of TEWL rates and SC 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborators: Galderma; Galderma R&D
• Treatments: Ivermectin

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