Ivermectin + Digital Interaction for Rosacea

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must be taking: Ivermectin

Disqualifiers: Other skin conditions, Ivermectin allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether digital tools can help people with rosacea adhere to their ivermectin treatment. It tests three groups: one uses only the treatment, another receives weekly surveys about treatment habits, and the last uses a device to monitor skin moisture. The aim is to determine if these additional steps help patients stay on track with their medication and prevent symptom recurrence. Ideal participants have rosacea, understand English, and own a smartphone. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using ivermectin for rosacea, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that using ivermectin cream once a day is generally safe for treating rosacea. In research involving 1,555 patients, some experienced mild side effects. The most common were a burning sensation on the skin (1.3%), skin irritation (1.0%), and itching (0.8%). These side effects were mild and occurred in only a few users. The FDA has approved ivermectin cream for treating rosacea, supporting its safety for this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how digital interaction and monitoring can enhance rosacea treatment with ivermectin. Unlike standard care that typically involves topical or oral treatments without much follow-up, this trial tests innovative methods to boost treatment adherence and engagement. By using electronic monitors and digital surveys, the trial aims to gather valuable data on patient behavior and treatment effectiveness, potentially leading to more personalized and efficient rosacea management strategies.

What evidence suggests that this trial's treatments could be effective for rosacea?

Studies have shown that topical ivermectin effectively treats papulopustular rosacea, a skin condition causing redness and bumps. Research indicates that patients using ivermectin cream experienced significant improvements, including fewer skin lesions and enhanced quality of life. Additionally, ivermectin generally causes few side effects and is well-tolerated. In this trial, participants in the GPSkin group will use the GPSkin Barrier® device to measure skin moisture levels. This device helps track skin health and encourages better adherence to treatment, which is important for maintaining results and preventing flare-ups. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Rosacea.

Subjects without a known allergy to ivermectin

Subjects with access to a smart phone

Exclusion Criteria

I have a skin condition that is not rosacea.

Subject does not have a working knowledge of English.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily ivermectin therapy with adherence monitored electronically. Randomized groups receive additional interventions such as weekly digital surveys or daily hydration measurements.

12 weeks

1 visit (in-person) at 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adherence and hydration levels.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Interaction
• GPSkin
• Ivermectin

Trial Overview

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.

How Is the Trial Designed?

Group I: GPSkin group Experimental Treatment 2 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 Group Experimental Treatment 2 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 Group Experimental Treatment 1 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.

Ivermectin is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Stromectol for:

• Strongyloidiasis
• Onchocerciasis

Approved in European Union as Mectizan for:

• Onchocerciasis
• Strongyloidiasis

Approved in Canada as Ivermectin for:

• Strongyloidiasis
• Onchocerciasis

Approved in Japan as Ivermectin for:

• Strongyloidiasis
• Onchocerciasis

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Galderma R&D

Industry Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04275999

Study Details | NCT04275999 | Rosacea and Ivermectin

The primary hypothesis is that weekly digital interactions and routine measurement of TEWL rates and SC hydration levels will promote patient adherence to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7984125/

Value of GPSkin for the measurement of skin barrier ...

The GPSkin determines TEWL and SCH accurately in healthy and impaired skin barrier state and can monitor skin barrier function in rosacea during treatment.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32573826/

Value of GPSkin for the measurement of skin barrier ...

The GPSkin determines TEWL and SCH accurately in healthy and impaired skin barrier state and can monitor skin barrier function in rosacea during treatment.

4.

clinicaltrial.be

clinicaltrial.be/en/details/4018?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Rosacea and Ivermectin

All subjects will receive ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea. The digital ...

5.

journals.lww.com

journals.lww.com/cmj/fulltext/2023/08050/evaluation_of_skin_barrier_function_based_on_skin.17.aspx

Evaluation of skin barrier function based on skin...

Hence, we analyzed dermoscopic images as a skin barrier function evaluation method and compared the results with those of the GPSkin Barrier, ...

6.

vionausa.com

vionausa.com/wp-content/uploads/2023/07/Ivermectin-Cream_SDS.pdf

Safety Data Sheet Ivermectin Cream, 1% Strength

Safety Data Sheet. Ivermectin Cream, 1%. Strength: 1%. Pack Size: 30 gram ... lesions of rosacea received ivermectin cream once daily. A total of 1,555 ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5749619/

Topical Ivermectin: Data Supporting Dual Modes of Action ...

Several publications support the efficacy and safety of IVM 1% cream applied once daily for treatment of rosacea, based on pivotal Phase III studies, long-term ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/ivermectin-topical-application-route/description/drg-20075441

Ivermectin (topical application route) - Side effects & dosage

Ivermectin 1% topical cream is used to treat lesions of rosacea. ... Safety and efficacy have not been established. Geriatric. Appropriate ...

9.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2014/206255lbl.pdf

SOOLANTRA™(ivermectin) cream - accessdata.fda.gov

SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea. 2. DOSAGE AND ADMINISTRATION. Apply to the affected areas of the face once ...

10.

nice.org.uk

nice.org.uk/advice/esnm68/chapter/full-evidence-summary

Inflammatory lesions of papulopustular rosacea: ivermectin ...

The most common adverse events associated with ivermectin 10 mg/g were skin burning sensation (1.3%), skin irritation (1.0%), pruritus (0.8%) ...