Papulopustular Rosacea Clinical Trial
— ATTRACTOfficial 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 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
Status | Completed |
Enrollment | 962 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA), - Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face. Exclusion Criteria: - Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilar, or seborrheic dermatitis and acne, - Subjects with rosacea with more than two nodules on the face. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bulgaria | Galderma Investigational Site | Pleven | |
Bulgaria | Galderma Investigational Site | Plovdiv | |
Bulgaria | Galderma Investigational Site | Sofia | |
Czech Republic | Galderma Investigational Site | Chomutov | |
Czech Republic | Galderma Investigational Site | Hradec Kralove | |
Czech Republic | Galderma Invetigational site | Olomouc | |
Czech Republic | Galderma Investigational Site | Pardubice | |
Czech Republic | Galderma Investigational Site | Praha 1 | |
Czech Republic | Galderma Investigational Site | Slany | |
France | 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 | |
Germany | 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 | Munster | |
Germany | Galderma Investigational Site | Tubingen | |
Germany | Galderma Investigational Site | Wuppertal | |
Hungary | 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 | Pecel | |
Hungary | Galderma Investigational Site | Szeged | |
Hungary | Galderma Investigational Site | Szekszard | |
Hungary | Galderma Investigational Site | Szolnok | |
Poland | Galderma Investigational Site | Bialystok | |
Poland | Galderma Investigational Site | Gdansk | |
Poland | Galderma Investigational Site | Krakow | |
Poland | Galderma Investigational Site | Warszawa | |
Poland | Galderma Investigational Site | Wroclaw | |
Romania | Galderma Investigational Site | Brasov | |
Romania | Galderma Investigational Site | Bucharest | |
Romania | Galderma Investigational Site | Craiova | |
Romania | Galderma Investigational Site | Timisoara | |
Romania | Galderma Investigational Site | Tirgu Mures | |
Russian Federation | Galderma Investigational Site | Chelyabinsk | |
Russian Federation | Galderma Investigational Site | Lipetsk | |
Russian Federation | Galderma Investigational Site | Moscow | |
Russian Federation | Galderma Investigational Site | Nizhny Novgorod | |
Ukraine | Galderma Investigational Site | Dnipropetrovsk | |
Ukraine | Galderma Investigational Site | Donetsk | |
Ukraine | Galderma Investigational Site | Kiev | |
Ukraine | Galderma Investigational Site | Lviv | |
Ukraine | Galderma Investigational Site | Uzhgorod | |
United Kingdom | Galderma Investigational Site | Berkshire | |
United Kingdom | Galderma Investigational Site | Bexhill | |
United Kingdom | Galderma Investigational Site | London | |
United Kingdom | Galderma Investigational Site | Nuneaton |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
Bulgaria, Czech Republic, France, Germany, Hungary, Poland, Romania, Russian Federation, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to Relapse | Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'. | Week 16 up to Week 52 | No |
Primary | Percent Change in Inflammatory Lesions From Baseline to Week 16 | Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period | Baseline and Week 16 | No |
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