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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights

Study Summary

This trial will test whether or not weekly digital interactions and routine measurement of TEWL rates and SC hydration levels will help patients stick to their ivermectin therapy and prevent disease relapse.

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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with Rosacea.
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence - Drug Weight
Adherence - Drug Weight Change
Adherence - MEMs Cap
+3 more

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

Find a Location

Who is running the clinical trial?

Galderma R&DIndustry Sponsor
298 Previous Clinical Trials
60,300 Total Patients Enrolled
28 Trials studying Rosacea
13,151 Patients Enrolled for Rosacea
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,207 Total Patients Enrolled
2 Trials studying Rosacea
30 Patients Enrolled for Rosacea
Steven R Feldman, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
14 Previous Clinical Trials
573 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being recruited for this research project at present?

"The clinical trial in question is not presently looking for patients. The clinical trial was originally posted on 4/16/2021 and was last edited on 9/26/2022. Although this clinical trial is not searching for patients anymore, there are 36 other clinical trials currently enrolling participants right now."

Answered by AI

For this particular test, are elderly individuals being included?

"The age range for this clinical trial is 18 to 80. If you are not in that age bracket, there might be other trials more suitable for you as there 11 ongoing trials for people under 18 and 32 for those 65 and older."

Answered by AI

What are the most popular conditions that ivermectin is used to treat?

"Ascaris lumbricoides, or roundworm, is commonly treated with the medication ivermectin. This drug can also help to manage strongyloidiasis caused by Strongyloides stercoralis infection, enterobiasis, and demodex infestation."

Answered by AI

Could I join this clinical trial?

"Eligible patients between 18-80 years old who have rosacea may be accepted into the trial. In addition to the age requirement, participants must also: understand English, not have an allergy to ivermectin, and own a smart phone."

Answered by AI

How many patients are being evaluated in this clinical trial?

"As of 9/26/2022, this particular study is not recruiting any new participants. Although, there are 13 other trials for rosacea and 23 for ivermectin that are still enrolling patients."

Answered by AI

What are the possible side effects associated with ivermectin?

"Ivermectin's Phase 2 status indicates that while there is evidence of its safety, there is currently no data to support its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

My rosacea seems to be getting worse. Previously flare ups with pimples used to take up to a week to clear up; now it is taking 3-4 weeks. The flare ups are more frequent, and I don't feel I can go out in public without covering with make-up. It's time to do something about it.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

~0 spots leftby May 2024