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

Primary Purpose

Rosacea

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ivermectin

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCSD Division of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ivermectin

Arm Description

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

Outcomes

Primary Outcome Measures

Relative Trypsin-like Enzyme Activity

Activity was quantified using a protease activity assay involving aprotinin, a known selective inhibitor of trypsin-related enzyme activity

Secondary Outcome Measures

Relative Fold Change in Cathelicidin mRNA

Ratio of fold change in cathelicidin mRNA at 12 weeks to fold change in cathelicidin mRNA at baseline

Full Information

NCT ID

NCT02806414

First Posted

June 15, 2016

Last Updated

October 1, 2021

Sponsor

University of California, San Diego

Collaborators

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02806414

Brief Title

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

Official Title

A Single Site Evaluation of the Inhibitory Effects of Topical Ivermectin on Serine Protease Activity and Production of LL-37 Cathelicidin Peptide, Biochemical Markers of Rosacea-specific Inflammation and on the Skin Microbiome in Rosacea.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ivermectin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ivermectin

Other Intervention Name(s)

Soolantra

Primary Outcome Measure Information:

Title

Relative Trypsin-like Enzyme Activity

Description

Activity was quantified using a protease activity assay involving aprotinin, a known selective inhibitor of trypsin-related enzyme activity

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Relative Fold Change in Cathelicidin mRNA

Description

Ratio of fold change in cathelicidin mRNA at 12 weeks to fold change in cathelicidin mRNA at baseline

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tissa Hata, MD

Organizational Affiliation

UCSD Division of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Division of Dermatology

City

San Diego

State/Province

California

ZIP/Postal Code

92122

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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