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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01493947
First received: December 15, 2011
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Papulopustular Rosacea
 Drug: CD5024
Drug: Metronidazole 0.75% cream
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • Percent change in inflammatory lesions from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 960
Study Start Date: April 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD5024 Drug: CD5024
CD5024 applied once daily on the face during 16-week plus 36-week extension period.
Other Name: CD5024
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493947

  Show 60 Study Locations
Sponsors and Collaborators
Galderma R&D
  More Information

No publications provided

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01493947     History of Changes
Other Study ID Numbers: RD.03.SPR.40173
Study First Received: December 15, 2011
Last Updated: February 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Germany: Ethics Commission
Germany: Ministry of Health
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Bulgaria: Ethics committee
Bulgaria: Bulgarian Drug Agency
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Hungary: Ministry of Health, Social and Family Affairs
Hungary: Research Ethics Medical Committee
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Ukraine: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013