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

This study has been completed.
Information provided by (Responsible Party):
Galderma R&D Identifier:
First received: December 15, 2011
Last updated: September 22, 2015
Last verified: September 2015

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

Condition Intervention Phase
Papulopustular Rosacea
Drug: Ivermectin 1% cream
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:

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 ]
    Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period

Other Outcome Measures:
  • Time to Relapse [ Time Frame: Week 16 up to Week 52 ] [ Designated as safety issue: No ]
    Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.

Enrollment: 962
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ivermectin 1% cream Drug: Ivermectin 1% cream
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
Other Name: Soolantra
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01493947

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

Responsible Party: Galderma R&D Identifier: NCT01493947     History of Changes
Other Study ID Numbers: RD.03.SPR.40173 
Study First Received: December 15, 2011
Results First Received: June 29, 2015
Last Updated: September 22, 2015
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:
Skin Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on January 14, 2017