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

September 22, 2015 updated by: Galderma R&D

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 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

962

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Galderma Investigational Site
      • Plovdiv, Bulgaria
        • Galderma Investigational Site
      • Sofia, Bulgaria
        • Galderma Investigational Site
  • Czech Republic
      • Chomutov, Czech Republic
        • Galderma Investigational Site
      • Hradec Kralove, Czech Republic
        • Galderma Investigational Site
      • Olomouc, Czech Republic
        • Galderma Invetigational site
      • Pardubice, Czech Republic
        • Galderma Investigational Site
      • Praha 1, Czech Republic, 110 00
        • Galderma Investigational Site
      • Slany, Czech Republic, 27 401
        • Galderma Investigational Site
  • France
      • 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
  • Germany
      • Augsburg, Germany
        • Galderma Investigational Site
      • Berlin, Germany, 13 507
        • Galderma Investigational Site
      • Bonn, Germany
        • Galderma Investigational Site
      • Darmstadt, Germany, 64 297
        • Galderma Investigational Site
      • Dresden, Germany
        • Galderma Investigational Site
      • Hamburg, Germany
        • Galderma Investigational Site
      • Langenau, Germany, 89 129
        • Galderma Investigational Site
      • Mahlow, Germany, 15 831
        • 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
  • Hungary
      • Budapest, Hungary, 052
        • Galderma Investigational Site
      • Budapest, Hungary, 1135
        • Galderma Investigational Site
      • Budapest, Hungary, 1238
        • Galderma Investigational Site
      • Budapest, Hungary
        • Galderma Investigational Site
      • Debrecen, Hungary, 4032
        • Galderma Investigational Site
      • Miskolc, Hungary
        • Galderma Investigational Site
      • Pecel, Hungary, 21 19
        • Galderma Investigational Site
      • Szeged, Hungary
        • Galderma Investigational Site
      • Szekszard, Hungary
        • Galderma Investigational Site
      • Szolnok, Hungary
        • Galderma Investigational Site
  • Poland
      • 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
  • Romania
      • 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
  • Russian Federation
      • 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
  • Ukraine
      • 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
  • United Kingdom
      • Berkshire, United Kingdom
        • Galderma Investigational Site
      • Bexhill, United Kingdom
        • Galderma Investigational Site
      • London, United Kingdom
        • Galderma Investigational Site
      • Nuneaton, United Kingdom
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and Week 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)'.
Week 16 up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 16, 2011

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.40173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Papulopustular Rosacea

Clinical Trials on Ivermectin 1% cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe