CD5024 1% Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study - Full Text View

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

This study is currently recruiting participants.

Verified April 2012 by Galderma R&D

First Received on December 15, 2011. Last Updated on April 19, 2012 History of Changes

Sponsor:	Galderma R&D
Information provided by (Responsible Party):	Galderma R&D
ClinicalTrials.gov Identifier:	NCT01493947

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

Drug Information available for: Metronidazole Metronidazole hydrochloride

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:	October 2013
Estimated Primary Completion Date:	October 2013 (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

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

Contacts

Contact: Marie-Hélène PEIRONE, MBsc	+33 4 93 95 71 71	marie-helene.peirone@galderma.com
Contact: Jean-Charles DHUIN, MBsc	+33 4 92 95 29 21	jean-charles.dhuin@galderma.com

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:	April 19, 2012
Health Authority:	France: Afssaps - French Health Products Safety Agency 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 and Social Development 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, 2012