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

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ClinicalTrials.gov Identifier: NCT01493947
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:

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 or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: Ivermectin 1% cream Drug: Metronidazole 0.75% cream Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 962 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : April 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percent Change in Inflammatory Lesions From Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
    Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period


Other Outcome Measures:
  1. Time to Relapse [ Time Frame: Week 16 up to Week 52 ]
    Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493947


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Sponsors and Collaborators
Galderma R&D

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01493947     History of Changes
Other Study ID Numbers: RD.03.SPR.40173
First Posted: December 16, 2011    Key Record Dates
Results First Posted: October 28, 2015
Last Update Posted: October 28, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Ivermectin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents