CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
NCT ID: NCT01493947
Last Updated: 2015-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
962 participants
INTERVENTIONAL
2012-04-30
2013-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ivermectin 1% cream
Ivermectin 1% cream
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
Metronidazole 0.75% cream
Metronidazole 0.75% cream
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Interventions
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Ivermectin 1% cream
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
Metronidazole 0.75% cream
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion Criteria
* Subjects with rosacea with more than two nodules on the face.
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Investigational Site
Pleven, , Bulgaria
Galderma Investigational Site
Plovdiv, , Bulgaria
Galderma Investigational Site
Sofia, , Bulgaria
Galderma Investigational Site
Chomutov, , Czechia
Galderma Investigational Site
Hradec Králové, , Czechia
Galderma Invetigational site
Olomouc, , Czechia
Galderma Investigational Site
Pardubice, , Czechia
Galderma Investigational Site
Prague, , Czechia
Galderma Investigational Site
Slaný, , Czechia
Galderma Investigational Site
Bordeaux, , France
Galderma Investigational Site
Brest, , France
Galderma Investigational Site
Cannes, , France
Galderma Investigational Site
Nice, , France
Galderma Investigational Site
Saint-Etienne, , France
Galderma Investigational Site
Augsburg, , Germany
Galderma Investigational Site
Berlin, , Germany
Galderma Investigational Site
Bonn, , Germany
Galderma Investigational Site
Darmstadt, , Germany
Galderma Investigational Site
Dresden, , Germany
Galderma Investigational Site
Hamburg, , Germany
Galderma Investigational Site
Langenau, , Germany
Galderma Investigational Site
Mahlow, , Germany
Galderma Investigational Site
Mainz, , Germany
Galderma Investigational Site
Munich, , Germany
Galderma Investigational Site
Münster, , Germany
Galderma Investigational Site
Tübingen, , Germany
Galderma Investigational Site
Wuppertal, , Germany
Galderma Investigational Site
Budapest, , Hungary
Galderma Investigational Site
Budapest, , Hungary
Galderma Investigational Site
Budapest, , Hungary
Galderma Investigational Site
Budapest, , Hungary
Galderma Investigational Site
Debrecen, , Hungary
Galderma Investigational Site
Miskolc, , Hungary
Galderma Investigational Site
Pécel, , Hungary
Galderma Investigational Site
Szeged, , Hungary
Galderma Investigational Site
Szekszárd, , Hungary
Galderma Investigational Site
Szolnok, , Hungary
Galderma Investigational Site
Bialystok, , Poland
Galderma Investigational Site
Gdansk, , Poland
Galderma Investigational Site
Krakow, , Poland
Galderma Investigational Site
Warsaw, , Poland
Galderma Investigational Site
Wroclaw, , Poland
Galderma Investigational Site
Brasov, , Romania
Galderma Investigational Site
Bucharest, , Romania
Galderma Investigational Site
Craiova, , Romania
Galderma Investigational Site
Târgu Mureş, , Romania
Galderma Investigational Site
Timișoara, , Romania
Galderma Investigational Site
Chelyabinsk, , Russia
Galderma Investigational Site
Lipetsk, , Russia
Galderma Investigational Site
Moscow, , Russia
Galderma Investigational Site
Nizhny Novgorod, , Russia
Galderma Investigational Site
Dnipropetrovsk, , Ukraine
Galderma Investigational Site
Donetsk, , Ukraine
Galderma Investigational Site
Kiev, , Ukraine
Galderma Investigational Site
Lviv, , Ukraine
Galderma Investigational Site
Uzhhorod, , Ukraine
Galderma Investigational Site
Berkshire, , United Kingdom
Galderma Investigational Site
Bexhill-on-Sea, , United Kingdom
Galderma Investigational Site
London, , United Kingdom
Galderma Investigational Site
Nuneaton, , United Kingdom
Countries
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Other Identifiers
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RD.03.SPR.40173
Identifier Type: -
Identifier Source: org_study_id
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