NCT01493947

CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 962 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Papulopustular Rosacea

Interventions

Type	Name	Description
DRUG	Ivermectin 1% cream	Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
DRUG	Metronidazole 0.75% cream	Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-12-16
• Last updated: 2015-10-28
• Results posted: 2015-10-28

Locations

60 sites across 10 countries: Bulgaria, Czechia, France, Germany, Hungary, Poland, Romania, Russia, Ukraine, United Kingdom