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Anti-parasitic

Ivermectin + Digital Interaction for Rosacea

Phase 2

Waitlist Available

Led By Steven R Feldman, MD, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject with a diagnosis of Rosacea

Subject is 18 years of age or older.

Must not have

Subject with a diagnosed skin condition other than rosacea

Subjects under 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using a skin cream, online surveys, and a skin moisture measuring device can help patients with rosacea stick to their treatment and prevent their condition from getting worse.

Who is the study for?

This trial is for adults over 18 with rosacea who have a smartphone and can communicate in English. They must not be allergic to ivermectin or have other skin conditions. The study aims to see if digital tools like surveys and hydration measurement devices help patients stick to their treatment.

What is being tested?

The trial tests whether weekly digital interactions or using a device that measures skin hydration (TEWL rates and SC levels) can improve adherence to daily maintenance therapy with the drug ivermectin for rosacea. Patients' use of medication will be tracked electronically.

What are the potential side effects?

While specific side effects are not listed, Ivermectin may cause skin irritation, dryness, or burning sensations when used topically for rosacea. Allergic reactions could occur in those sensitive to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Rosacea.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin condition that is not rosacea.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence - Drug Weight

Adherence - Drug Weight Change

Adherence - MEMs Cap

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: GPSkin groupExperimental Treatment2 Interventions

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.

Group II: Digital Interaction GroupExperimental Treatment2 Interventions

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.

Group III: Control GroupExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ivermectin

2007

Completed Phase 4

~2380

0 / 4Eligibility criteria met