CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study (ATTRACT)
|ClinicalTrials.gov Identifier: NCT01493947|
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
- 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
|Condition or disease||Intervention/treatment||Phase|
|Papulopustular Rosacea||Drug: Ivermectin 1% cream Drug: Metronidazole 0.75% cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||962 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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.|
|Study Start Date :||April 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
|Experimental: Ivermectin 1% cream||
Drug: Ivermectin 1% cream
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
Other Name: Soolantra
|Active Comparator: Metronidazole 0.75% cream||
Drug: Metronidazole 0.75% cream
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Other Name: Metronidazole
- Percent Change in Inflammatory Lesions From Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
- Time to Relapse [ Time Frame: Week 16 up to Week 52 ]Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493947
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