CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study (ATTRACT)
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|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|
|Actual Primary Completion Date :||December 2013|
|Actual 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)'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493947