Trial Outcomes & Findings for Rosacea and Ivermectin (NCT NCT04275999)

NCT ID: NCT04275999

Last Updated: 2026-03-27

Results Overview

Electronic monitoring of the ivermectin

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Month 3

Results posted on

2026-03-27

Participant Flow

All enrolled participants received the same treatment - all subjects received ivermectin cream 1% to use once daily for 3 months

subjects were only enrolled in the Digital Interaction Group - all subjects received ivermectin cream 1% to use once daily for 3 months

Participant milestones

Participant milestones
Measure	GPSkin Group No Subjects were enrolled in the GPSkin Group - all subjects received ivermectin cream 1% to use once daily for 3 months	Digital Interaction Group 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. ivermectin: 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 interaction: 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.	Control Group No Subjects were enrolled in the Control Group - all subjects received ivermectin cream 1% to use once daily for 3 months
Overall Study STARTED	0	30	0
Overall Study COMPLETED	0	27	0
Overall Study NOT COMPLETED	0	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GPSkin Group No Subjects were enrolled in the GPSkin Group - all subjects received ivermectin cream 1% to use once daily for 3 months	Digital Interaction Group 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. ivermectin: 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 interaction: 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.	Control Group No Subjects were enrolled in the Control Group - all subjects received ivermectin cream 1% to use once daily for 3 months
Overall Study Lost to Follow-up	0	2	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Rosacea and Ivermectin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group subjects were only enrolled in the Digital Interaction Group	Digital Interaction Group n=30 Participants 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. ivermectin: 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 interaction: 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.	GPSkin Group subjects were only enrolled in the Digital Interaction Group	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants
Age, Categorical Between 18 and 65 years	—	22 Participants n=62 Participants	0 Participants n=123 Participants	22 Participants n=53 Participants
Age, Categorical >=65 years	—	8 Participants n=62 Participants	0 Participants n=123 Participants	8 Participants n=53 Participants
Age, Continuous	—	62 years n=62 Participants	—	62 years n=53 Participants
Sex: Female, Male Female	—	21 Participants n=62 Participants	—	21 Participants n=53 Participants
Sex: Female, Male Male	—	9 Participants n=62 Participants	—	9 Participants n=53 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=62 Participants	—	0 Participants n=53 Participants
Race (NIH/OMB) Asian	—	0 Participants n=62 Participants	—	0 Participants n=53 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=62 Participants	—	0 Participants n=53 Participants
Race (NIH/OMB) Black or African American	—	1 Participants n=62 Participants	—	1 Participants n=53 Participants
Race (NIH/OMB) White	—	28 Participants n=62 Participants	—	28 Participants n=53 Participants
Race (NIH/OMB) More than one race	—	1 Participants n=62 Participants	—	1 Participants n=53 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=62 Participants	—	0 Participants n=53 Participants
Region of Enrollment United States	—	30 participants n=62 Participants	—	30 participants n=53 Participants

PRIMARY outcome

Timeframe: Month 3

Population: 27 participants analyzed

Electronic monitoring of the ivermectin

Outcome measures

Outcome measures
Measure	Control Group subjects were only enrolled in the Digital Interaction Group 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: 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 Interaction Group n=27 Participants 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. ivermectin: 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 interaction: 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.	GPSkin Group subjects were only enrolled in the Digital Interaction Group 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. ivermectin: 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. GPSkin: 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.
Adherence - MEMs Cap Adherence month 2: · Adherent	—	15 Participants	—
Adherence - MEMs Cap Adherence month 2: · Non-Adherent	—	12 Participants	—
Adherence - MEMs Cap Adherence month 1: · Adherent	—	21 Participants	—
Adherence - MEMs Cap Adherence month 1: · Non-Adherent	—	6 Participants	—
Adherence - MEMs Cap Adherence month 3: · Adherent	—	14 Participants	—
Adherence - MEMs Cap Adherence month 3: · Non-Adherent	—	13 Participants	—

PRIMARY outcome

Timeframe: Baseline

Population: Medication Event Monitoring System (MEMS) cap technology that was used for adherence does not capture medication weights (date and time of bottle openings only) - no weights captured because of the adherence technology used - weights were inadvertently not collected any other way and will not be collected as study is closed

the ivermectin will be weighed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Change from baseline to Month 3

the ivermectin will be weighed

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Digital Interaction Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GPSkin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Administrative Coordinator

Wake Forest

Phone: 3367162903

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place