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CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

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: NCT02189629
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : September 17, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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Brief Summary:
Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CD5789 (trifarotene) Phase 3

Detailed Description:
To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
Actual Study Start Date : February 23, 2015
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
Experimental: CD5789 (trifarotene) cream Drug: CD5789 (trifarotene)


Outcome Measures
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Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) Success Rate up to Week 52 [ Time Frame: From Baseline to Week 52 ]
    Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).


Secondary Outcome Measures :
  1. Physician Global Assessment (PGA) Success Rate up to Week 52 [ Time Frame: From Baseline to Week 52 ]
    Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).


Eligibility Criteria
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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
  • The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.
  • Exclusion Criteria:
  • The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
  • The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
  • The Subject has any acne cyst on the face at Screening and at Baseline visits.
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): NCT02189629


Locations
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United States, Alabama
Galderma Investigational Site
Mobile, Alabama, United States, 36608
United States, Arkansas
Galderma Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Galderma Investigational Site
Sacramento, California, United States, 95819
Galderma Investigational Site
San Diego, California, United States, 92123
United States, Florida
Galderma Investigational Site
Miami, Florida, United States, 33175
Galderma Investigational Site
Miramar, Florida, United States, 33027
United States, Georgia
Galderma Investigational Site
Newnan, Georgia, United States, 30277
United States, Kentucky
Galderma Investigational Site
Louisville, Kentucky, United States, 40241
United States, New Mexico
Galderma Investigational Site
Albuquerque, New Mexico, United States, 87107
United States, New York
Galderma Investigational Site
New York, New York, United States, 10155
United States, North Carolina
Galderma Investigational Site
High Point, North Carolina, United States, 27262
United States, Ohio
Galderma Investigational Site
Beachwood, Ohio, United States, 44122
United States, Oregon
Galderma Investigational Site
Portland, Oregon, United States, 97210
United States, Tennessee
Galderma Investigational Site
Knoxville, Tennessee, United States, 37922
Czechia
Galderma Investigational Site
Chomutov, Czechia, 430 04
Galderma Investigational site
Hradec Kralove, Czechia, 500 05
Galderma Investigational Site
Olomouc, Czechia, 775 20
Galderma Investigational Site
Pardubice, Czechia, 532 03
Galderma Investigational site
Praha 1, Czechia, 110 00
Germany
Galderma Investigational Site
Augsburg, Germany, 86179
Galderma Investigational Site
Berlin, Germany, 10117
Galderma Investigational Site
Berlin, Germany, 13507
Galderma Investigational Site
Dessau, Germany, 06847
Galderma Investigational Site
Mahlow, Germany, 15831
Galderma Investigational Site
Muenster, Germany, 48149
Galderma Investigational Site
Wuppertal, Germany, 42287
Hungary
Galderma Investigational Site
Balatonfüred, Hungary, 8230
Galderma Investigational Site
Miskolc, Hungary, 3529
Galderma Investigational Site
Pécel, Hungary, 2119
Galderma Investigational Site
Szeged, Hungary, 6720
Galderma Investigational Site
Szekszard, Hungary, 7100
Galderma Investigational Site
Szolnok, Hungary, 5000
Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Kevin Chan Galderma R&D
  Study Documents (Full-Text)

Documents provided by Galderma R&D:
Study Protocol  [PDF] August 7, 2014
Statistical Analysis Plan  [PDF] August 12, 2015

More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02189629    
Other Study ID Numbers: RD.06.SPR.18250
First Posted: July 14, 2014    Key Record Dates
Results First Posted: September 17, 2019
Last Update Posted: November 14, 2019
Last Verified: November 2019
Keywords provided by Galderma R&D:
Acne vulgaris
Safety
Face
Trunk
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
 Sebaceous Gland Diseases
Trifarotene
Dermatologic Agents