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Rosacea and Ivermectin

Primary Purpose

Rosacea

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ivermectin
digital interaction
GPSkin
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rosacea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is 18 years of age or older.
  • Subject has a working knowledge of English.
  • Subject with a diagnosis of Rosacea
  • Subjects without a known allergy to ivermectin
  • Subjects with access to a smart phone

Exclusion Criteria:

  • Subjects under 18 years of age.
  • Subject does not have a working knowledge of English.
  • Subject with a diagnosed skin condition other than rosacea
  • Subjects with a known allergy to ivermectin
  • Subjects without access to a smart phone

Sites / Locations

  • Wake Forest Health Sciences Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control Group

Digital Interaction Group

GPSkin group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Adherence - MEMs Cap
Electronic monitoring of the ivermectin
Adherence - Drug Weight
the ivermectin will be weighed
Adherence - Drug Weight Change
the ivermectin will be weighed
Transepidermal water loss (TEWL) rates
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Transepidermal water loss (TEWL) rates
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Level of stratum corneum (SC) hydration
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Level of stratum corneum (SC) hydration.
Use of the GPSkin Barrier device a or a portable hydration measurement device that measures TEWL rates

Secondary Outcome Measures

Full Information

First Posted
February 17, 2020
Last Updated
September 20, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT04275999
Brief Title
Rosacea and Ivermectin
Official Title
Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Rosacea Following Application of Ivermectin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary hypothesis is that weekly digital interactions and routine measurement of TEWL rates and SC hydration levels will promote patient adherence to maintenance ivermectin therapy and prevent disease relapse. The project will consist of a trial in which thirty subjects with rosacea receive ivermectin therapy and are randomized to receive either no intervention, a weekly digital survey to assess patient's attitudes towards ivermectin therapy, or a portal hydration measurement device that measures TEWL rates and SC hydration levels. The study team will measure adherence objectively in all groups with electronic monitors attached to the containers of the ivermectin, which all subjects will be told to use daily for maintenance therapy. Additionally, the hydration measurement device can transmit data to an Internet server via a smartphone using Bluetooth technology, thereby allowing providers to monitor a patient's TEWL rate and SC levels.
Detailed Description
Subjects will be offered an opportunity to participate in the study. Subjects will either have a diagnosis of rosacea. A total of 30 subjects will be enrolled. After consent and basic demographics, a study team member will use the GPSkin Barrier® to measure the baseline moisture level of the face of all subjects. Subjects will also fill out questionnaires pertaining to quality of life, accountability, and severity of rosacea. Subjects will be randomized into one of three arms: the control group (n= 10), the digital interaction group (n=10), or the GPSkin group (n=10). All subjects will receive ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea. The digital interaction group will receive a survey by email each week asking about their use ivermectin generated by Causa Research. The subjects in 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 will return at 3 Months. At this visit, the data from the electronic adherence monitoring will be downloaded, the ivermectin will be weighed, and the subject will fill out the same questionnaires (quality of life, accountability, and severity of rosacea). The intervention subjects will be evaluated on their use of the GPSkin Barrier® to measure their stratum corneum hydration. Subjects not randomized to the email intervention group will receive an accountability questionnaire at the beginning and end of the study.

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
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The project will consist of a trial in which thirty subjects with rosacea receive ivermectin therapy and are randomized to receive either no intervention, a weekly digital survey to assess the subject's attitudes towards ivermectin therapy, or a portal hydration measurement device that measures TEWL rates and SC hydration levels. The study team will measure adherence objectively in all groups with electronic monitors attached to the containers of the ivermectin, which all subjects will be told to use daily for maintenance therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Arm Title
Digital Interaction Group
Arm Type
Experimental
Arm Description
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.
Arm Title
GPSkin group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ivermectin
Intervention Description
Subjects will be given the ivermectin with an electronic monitoring device attached with a return appointment at month 3 for end of study visit. Subjects will be instructed to use the ivermectin once daily.
Intervention Type
Behavioral
Intervention Name(s)
digital interaction
Other Intervention Name(s)
digital interaction survey with ivermectin
Intervention Description
Subjects will receive weekly digital interaction; an electronic survey asking about their use of the ivermectin which will have the electronic monitoring device attached. Subjects will be instructed to use the ivermectin once daily. They will have a 3 month return appointment for end of study visit.
Intervention Type
Device
Intervention Name(s)
GPSkin
Other Intervention Name(s)
GPSkin Barrier®
Intervention Description
Subjects in 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 with the electronic monitoring device once daily. They will be scheduled for a 3 month end of study visit.
Primary Outcome Measure Information:
Title
Adherence - MEMs Cap
Description
Electronic monitoring of the ivermectin
Time Frame
Month 3
Title
Adherence - Drug Weight
Description
the ivermectin will be weighed
Time Frame
Baseline
Title
Adherence - Drug Weight Change
Description
the ivermectin will be weighed
Time Frame
Change from baseline to Month 3
Title
Transepidermal water loss (TEWL) rates
Description
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Time Frame
Baseline
Title
Transepidermal water loss (TEWL) rates
Description
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Time Frame
Change from baseline to 3 months
Title
Level of stratum corneum (SC) hydration
Description
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Time Frame
Baseline
Title
Level of stratum corneum (SC) hydration.
Description
Use of the GPSkin Barrier device a or a portable hydration measurement device that measures TEWL rates
Time Frame
Change from baseline to 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 18 years of age or older. Subject has a working knowledge of English. Subject with a diagnosis of Rosacea Subjects without a known allergy to ivermectin Subjects with access to a smart phone Exclusion Criteria: Subjects under 18 years of age. Subject does not have a working knowledge of English. Subject with a diagnosed skin condition other than rosacea Subjects with a known allergy to ivermectin Subjects without access to a smart phone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

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Rosacea and Ivermectin

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