Trial Outcomes & Findings for Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation. (NCT NCT02806414)

Last Updated: 2021-10-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-10-05

Participant milestones
Measure	Ivermectin All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Ivermectin All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin
Overall Study Lost to Follow-up	2

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

Baseline characteristics by cohort
Measure	Ivermectin n=25 Participants All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	58.3 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

Timeframe: 12 weeks

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

Outcome measures
Measure	Ivermectin n=23 Participants All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin
Relative Trypsin-like Enzyme Activity	1.10 percentage of baseline Interval 0.58 to 1.4

Timeframe: 12 weeks

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

Outcome measures
Measure	Ivermectin n=11 Participants All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin
Relative Fold Change in Cathelicidin mRNA	3.25 ratio Interval 0.54 to 4.89

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Ivermectin n=25 participants at risk All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin
Skin and subcutaneous tissue disorders melanoma excision	4.0% 1/25 • Number of events 1 • Baseline visit to follow-up phone visit (4 months total)
Infections and infestations cold	4.0% 1/25 • Number of events 1 • Baseline visit to follow-up phone visit (4 months total)
Investigations mild bleeding	4.0% 1/25 • Number of events 1 • Baseline visit to follow-up phone visit (4 months total)
Infections and infestations ear infection	4.0% 1/25 • Number of events 1 • Baseline visit to follow-up phone visit (4 months total)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) epidermal inclusion cyst	4.0% 1/25 • Number of events 1 • Baseline visit to follow-up phone visit (4 months total)

UCSD Dermatology

Phone: 8586571697