RosaceaPhase 2NCT04275999
Rosacea and Ivermectin
A Phase 2 study testing ivermectin, digital interaction and GPSkin in people with Rosacea, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The primary hypothesis is that weekly digital interactions and routine measurement of Transepidermal Water Loss (TEWL) rates and Subcutaneous hydration levels will promote patient adherence to maintenance ivermectin therapy and prevent disease relapse. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rosacea
- What is being tested?
- ivermectin, digital interaction and GPSkin
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to 17 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences Dermatology
Winston-Salem, North Carolina, 27104
About this study
Official title: Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Rosacea Following Application of Ivermectin
The primary hypothesis is that weekly digital interactions and routine measurement of Transepidermal Water Loss (TEWL) rates and Subcutaneous 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.
Read the 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.
- Conditions
- Rosacea
- Being tested
- ivermectin, digital interaction, GPSkin
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivermectinDrug
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.
digital interactionBehavioural
Also called digital interaction survey with ivermectin
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.
GPSkinDevice
Also called GPSkin Barrier®
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | 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. Receives: Drug: ivermectin |
| Digital Interaction Group | Experimental | 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. Receives: Drug: ivermectin; Behavioral: digital interaction |
| GPSkin group | Experimental | 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. Receives: Drug: ivermectin; Device: GPSkin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence - MEMs Cap
Electronic monitoring of the ivermectin
Measured: Month 3
Adherence - Drug Weight
the ivermectin will be weighed
Measured: Baseline
Adherence - Drug Weight Change
the ivermectin will be weighed
Measured: Change from baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start16 Apr 2021
- Primary completion17 Jan 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275999
- Sponsor's protocol ID
- IRB00062694
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2020
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Rosacea Following Application of Ivermectin
- ClinicalTrials.gov ID
- NCT04275999
- Acronym / sponsor ID
- IRB00062694
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis is that weekly digital interactions and routine measurement of Transepidermal Water Loss (TEWL) rates and Subcutaneous 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Drug: ivermectinIn 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. |
| Digital Interaction Group | Experimental | Drug: ivermectin, Behavioral: digital interactionThe 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. |
| GPSkin group | Experimental | Drug: ivermectin, Device: GPSkinThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ivermectinSubjects 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. | Drug | Control Group, Digital Interaction Group, GPSkin group |
| digital interactionAlso: digital interaction survey with ivermectinSubjects 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. | Behavioural | Digital Interaction Group |
| GPSkinAlso: GPSkin Barrier®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. | Device | GPSkin group |
Primary outcome
Adherence - MEMs Cap
Time frame: Month 3
Electronic monitoring of the ivermectin
Adherence - Drug Weight
Time frame: Baseline
the ivermectin will be weighed
Adherence - Drug Weight Change
Time frame: Change from baseline to Month 3
the ivermectin will be weighed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Rosacea
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
Rosacea, Rosacea, Erythematotelangiectatic
Recruiting
Rosacea Radiofrequency Microneedling
Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ivermectin, digital interaction and GPSkin in people with Rosacea, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence - MEMs Cap (time frame: Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.