Clinical trial NCT04275999: Rosacea and Ivermectin
Official title: Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Rosacea Following Application of Ivermectin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Rosacea
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2020-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Adherence - MEMs Cap
timeFrame: Month 3
measure: Adherence - Drug Weight
timeFrame: Baseline
measure: Adherence - Drug Weight Change
timeFrame: Change from baseline to Month 3
measure: Transepidermal water loss (TEWL) rates
timeFrame: Baseline
measure: Transepidermal water loss (TEWL) rates
timeFrame: Change from baseline to 3 months
measure: Level of stratum corneum (SC) hydration
timeFrame: Baseline
measure: Level of stratum corneum (SC) hydration.
timeFrame: Change from baseline to 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: