CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Ivermectindrug
Likely dose
Not stated in record
Key inclusion· 5
  • Age 18–70 years old
  • Confirmed clinical diagnosis of rosacea with at least one inflammatory papule and at least mild erythema
  • Stable on concurrent medications for >3 months or unlikely to affect rosacea treatment
  • General good health per investigator
Key exclusion· 8
  • Steroid rosacea or pyoderma faciale (rosacea fulminans)
  • Facial topical therapies (OTC or prescription) within 28 days
  • Systemic corticosteroids or systemic antibiotics (esp. doxycycline, minocycline, tetracycline, metronidazole) within 28 days
  • Laser or light-based treatment for rosacea within 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02806414
NCT02806414Phase 2Completed

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.

University of California, San Diego·interventional·Posted Jun 20, 2016·Updated Oct 5, 2021

In Brief

A Phase 2 clinical trial evaluating Ivermectin for Rosacea. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRosacea
CountriesUnited States
CollaboratorsGalderma R&D

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 20, 2016
Enrollment StartJul 1, 2016
Primary CompletionJul 1, 2019
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 10.0 years ago

Interventions

Ivermectindrug