CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 962 enrolled
Drug / intervention
Ivermectin 1% cream +1 moredrug
Likely dose
Not stated in 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/NCT01493947
NCT01493947Phase 3Completed
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Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.

Galderma R&D·interventional·Posted Dec 16, 2011·Updated Oct 28, 2015

In Brief

A Phase 3 clinical trial evaluating Ivermectin 1% cream and Metronidazole 0.75% cream for Papulopustular Rosacea. Completed, enrolled 962 participants across 60 sites in 10 countries.

Detailed Summary

Study objectives: * To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. * And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapulopustular Rosacea
CountriesBulgaria, Czechia, France, Germany, Hungary, Poland, Romania, Russia, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2011
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.5 years ago

Interventions

Ivermectin 1% creamdrug

Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.

Metronidazole 0.75% creamdrug

Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.