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. (ATTRACT)

NCT01493947 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Galderma R&D
Phase	Phase 3
Status	COMPLETED
Enrolment	962
Start date	2012-04
Completion	2013-12

Conditions

• Papulopustular Rosacea

Interventions

• Ivermectin 1% cream
• Metronidazole 0.75% cream

Primary outcomes

• Percent Change in Inflammatory Lesions From Baseline to Week 16 — Baseline and Week 16
  Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period

Countries

Bulgaria, Czechia, France, Germany, Hungary, Poland, Romania, Russia, Ukraine, United Kingdom