Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation.

NCT ID: NCT02806414

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-05-31

Brief Summary

This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression and on the skin microbiome (the microorganisms that live on the skin) in rosacea. This is a single-site 16-week open-label study at University of California, San Diego. The investigators will do this by first measuring serine protease activity and cathelicidin and skin microbiome of all subjects. All subjects will receive Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks. Participants will return for monthly visits during which their clinical symptoms of facial redness and number of facial papules will be scored, and they will have repeat tape stripping and/or skin swabs. At the end of the study, tape strips and skin swabs will be analyzed to determine serine protease activity and skin microbiome of participants at each of their visits and expression of cathelicidin (LL-37) mRNA. The investigators will then look at changes in serine protease activity and LL-37 expression and skin microbiome over time, and they will also determine whether or not these changes correlate with disease severity.

Conditions

Rosacea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ivermectin

All subjects will be treated with topical ivermectin daily for up to 12 weeks.

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Interventions

Ivermectin

Intervention Type: DRUG

Other Intervention Names

Soolantra

Eligibility Criteria

Inclusion Criteria

• Subject is male or non-pregnant female, 18 - 70 years of age.
• Subjects willing and able to give informed consent.
• Subjects willing and able to comply with the requirements of the study.
• Subject has the clinical diagnosis of rosacea with at least one inflammatory papule and at least mild erythema.
• Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
• Subject is in general good health in the opinion of the investigator.
• Subject has normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study.

Exclusion Criteria

• Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans).
• Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days
• Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
• Subject has had laser or light-based treatment for rosacea within the prior 3 months.
• Subject has had systemic retinoids and retinoid derivatives over the past 6 months
• Subject has a known hypersensitivity or allergy to topical ivermectin or components of the vehicle.
• Subject is pregnant or lactating or planning a pregnancy during the duration of the study
• Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
• Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Tissa Hata, MD

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tissa Hata, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Division of Dermatology

Locations

UCSD Division of Dermatology

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UCSD 160765

Identifier Type: -

Identifier Source: org_study_id