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CD5024 1% Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

Information source: Galderma R&D
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea

Intervention: CD5024 (Drug); Metronidazole 0.75% cream (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma R&D

Summary

Study objectives:

- To compare efficacy and safety of CD5024 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,

CD5024 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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Percent change in inflammatory lesions from Baseline to Week 16

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 conglobata, rosacea fulminans,

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 pilaris, or seborrheic dermatitis and acne,

- Subjects with rosacea with more than two nodules on the face.

Locations and Contacts

Galderma Investigational Site, Pleven, Bulgaria

Galderma Investigational Site, Plovdiv, Bulgaria

Galderma Investigational Site, Sofia, Bulgaria

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 1 110 00, Czech Republic

Galderma Investigational Site, Slany 27 401, Czech Republic

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 13 507, Germany

Galderma Investigational Site, Bonn, Germany

Galderma Investigational Site, Darmstadt 64 297, Germany

Galderma Investigational Site, Dresden, Germany

Galderma Investigational Site, Hamburg, Germany

Galderma Investigational Site, Langenau 89 129, Germany

Galderma Investigational Site, Mahlow 15 831, 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, Germany

Galderma Investigational Site, Budapest 1238, Hungary

Galderma Investigational Site, Budapest 1135, Hungary

Galderma Investigational Site, Budapest 052, Hungary

Galderma Investigational Site, Budapest, Hungary

Galderma Investigational Site, Debrecen 4032, Hungary

Galderma Investigational Site, Miskolc, Hungary

Galderma Investigational Site, Pecel 21 19, Hungary

Galderma Investigational Site, Szeged, Hungary

Galderma Investigational Site, Szekszard, Hungary

Galderma Investigational Site, Szolnok, Hungary

Galderma Investigational Site, Bialystok, Poland

Galderma Investigational Site, Gdansk, Poland

Galderma Investigational Site, Krakow, Poland

Galderma Investigational Site, Warszawa, Poland

Galderma Investigational Site, Wroclaw, Poland

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, Romania

Galderma Investigational Site, Chelyabinsk, Russian Federation

Galderma Investigational Site, Lipetsk, Russian Federation

Galderma Investigational Site, Moscow, Russian Federation

Galderma Investigational Site, Nizhny Novgorod, Russian Federation

Galderma Investigational Site, Dnipropetrovsk, Ukraine

Galderma Investigational Site, Donetsk, Ukraine

Galderma Investigational Site, Kiev, Ukraine

Galderma Investigational Site, Lviv, Ukraine

Galderma Investigational Site, Uzhgorod, Ukraine

Galderma Investigational Site, Berkshire, United Kingdom

Galderma Investigational Site, Bexhill, United Kingdom

Galderma Investigational Site, London, United Kingdom

Galderma Investigational Site, Nuneaton, United Kingdom

Additional Information

Starting date: April 2012
Last updated: December 20, 2013

Page last updated: August 23, 2015

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