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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug ivermectin for treating rosacea?

Research shows that ivermectin 1% cream is effective in treating rosacea, improving symptoms and quality of life for patients. It works by reducing inflammation and has been found to be more effective than other treatments like metronidazole and azelaic acid. ^{1 2 3 4 5}

Is the combination of Ivermectin and Digital Interaction safe for treating rosacea?

Ivermectin, used for over 25 years, is generally safe for humans, with low rates of side effects when used for various conditions, including rosacea. Topical ivermectin has been shown to be well-tolerated and safe for treating rosacea in both short-term and long-term studies. ^{5 6 7 8 9}

How is the drug ivermectin unique in treating rosacea?

Ivermectin is unique for treating rosacea because it is a topical cream that works through dual modes of action: it has anti-inflammatory properties and targets Demodex mites, which may contribute to the condition. This makes it different from other treatments that might not address both inflammation and potential parasitic involvement. ^{1 2 5 8 10}

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of rosacea with topical ivermectin cream: a series of 34 cases. [2017]

2. Poland pubmed.ncbi.nlm.nih.gov

New indications for topical ivermectin 1% cream: a case series study. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Ivermectin: A Review in Rosacea. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of topical ivermectin and impact on quality of life in patients with papulopustular rosacea: A systematic review and meta-analysis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Topical Ivermectin: Data Supporting Dual Modes of Action in Rosacea. [2020]

6. France pubmed.ncbi.nlm.nih.gov

[Ivermectin]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Over 25 Years of Clinical Experience With Ivermectin: An Overview of Safety for an Increasing Number of Indications. [2016]

8. Spain pubmed.ncbi.nlm.nih.gov

The treatment of rosacea with topical ivermectin. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Clinical picture and outcome of Serious Adverse Events in the treatment of Onchocerciasis. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The efficacy, safety, and tolerability of ivermectin compared with current topical treatments for the inflammatory lesions of rosacea: a network meta-analysis. [2020]