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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
962

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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