CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 273 enrolled
Drug / intervention
Ivermectin 1% cream +2 moredrug
Likely dose
Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsulesfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03075891
NCT03075891Phase 4Completed
CompareCT.gov

Efficacy Comparison of Ivermectin 1% Topical Cream Associated With Doxycycline 40 mg Modified Release (MR) Capsules Versus Ivermectin 1% Topical Cream Associated With Placebo in the Treatment of Severe Rosacea

Galderma R&D·interventional·Posted Mar 9, 2017·Updated Mar 16, 2021

In Brief

A Phase 4 clinical trial evaluating Ivermectin 1% cream, Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules, and 1 other intervention for Rosacea. Completed, enrolled 273 participants across 21 sites in 3 countries.

Detailed Summary

The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRosacea
CountriesCanada, Hungary, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartJul 5, 2017
Primary CompletionFeb 8, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.3 years ago

Interventions

Ivermectin 1% creamdrug

Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks

Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsulesdrug

1 Capsule once-daily for 12 weeks

Oral placebo capsulesother

1 Capsule once-daily for 12 weeks