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Phase 3 Papulopustular Rosacea Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01493687
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : January 16, 2015
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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Brief Summary:
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea (PPR) Drug: CD5024 Drug: Azelaic acid 15% Gel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
Study Start Date : December 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arms and Interventions
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Arm Intervention/treatment
Experimental: CD5024
CD5024 1% Cream
 Drug: CD5024
CD5024 1% Cream, once daily
Placebo Comparator: CD5024 Vehicle
CD5024 Vehicle Cream
 Drug: Azelaic acid 15% Gel
Topical Gel applied twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Success Rate [ Time Frame: Week 12 ]

    Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.

    Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:

    Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)


  2. Absolute Change in Inflammatory Lesion Count [ Time Frame: Baseline to Week 12 ]
    Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).


Secondary Outcome Measures :
  1. Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) [ Time Frame: Baseline to Week 12 ]
    Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
  2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.

Exclusion Criteria:

  1. The subject has 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, seborrheic dermatitis, and acne,
  2. The subject has rosacea with more than two nodules on the face.
Contacts and Locations
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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): NCT01493687


Locations
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Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Michael Graeber, M.D. Galderma R&D, LLC
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01493687    
Other Study ID Numbers: RD.06.SPR.18170
First Posted: December 16, 2011    Key Record Dates
Results First Posted: January 16, 2015
Last Update Posted: February 18, 2021
Last Verified: January 2015
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents