At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 463 enrolled
Drug / intervention
CLS001 (Omiganan) +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.
A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension
In Brief
A Phase 3 clinical trial evaluating CLS001 (Omiganan) and Vehicle for Rosacea. Completed, enrolled 463 participants across 41 sites in 9 countries.
Detailed Summary
This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRosacea
CountriesAustralia, Canada, France, Germany, Netherlands, New Zealand, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartDec 2015
Primary CompletionJul 2017
Study CompletionApr 2018
TodayJul 2026
First PostedSep 11, 2015
Enrollment StartDec 1, 2015
Primary CompletionJul 5, 2017
Study CompletionApr 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago
Interventions
CLS001 (Omiganan)drug
Topical gel
Vehicledrug
Vehicle Gel