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Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02566369
Recruitment Status : Completed
First Posted : October 2, 2015
Results First Posted : August 22, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CD5789 (trifarotene) 50μg/g cream Drug: Placebo cream Phase 3

Detailed Description:
Clinical Trial for each subject is approximately 14 weeks and are randomized to one of the two treatments for 12 weeks. Subjects must be 9 years of age and older with acne vulgaris.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: CD5789 (trifarotene) 50μg/g Cream
CD5789 (trifarotene) 50μg/g Cream
Drug: CD5789 (trifarotene) 50μg/g cream
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.

Placebo Comparator: Placebo Cream
Placebo cream
Drug: Placebo cream
Placebo cream applied once daily for 12 weeks




Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) Success Rate at Week 12 [ Time Frame: From Baseline to Week 12 ]
    Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.



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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 is a male or female, 9 years of age or older, at Screening visit.
  • The Subject has moderate acne at Screening and Baseline.
  • The subject is a female of non childbearing potential
  • The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.

Exclusion Criteria:

  • The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
  • The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial.
  • The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.)
  • The subject is unwilling to refrain from use of prohibited medication during the clinical trial

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): NCT02566369


  Show 124 Study Locations
Sponsors and Collaborators
Galderma R&D
Investigators
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Principal Investigator: Jerry Tan, MD Windsor Clinical Research
Principal Investigator: Ulrike Blume-Peytavi, MD Charité Universitätsmedizin
  Study Documents (Full-Text)

Documents provided by Galderma R&D:
Study Protocol  [PDF] March 10, 2017
Statistical Analysis Plan  [PDF] October 5, 2015


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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02566369     History of Changes
Other Study ID Numbers: RD.06.SPR.18251
First Posted: October 2, 2015    Key Record Dates
Results First Posted: August 22, 2019
Last Update Posted: November 11, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galderma R&D:
Efficacy
Safety
Acne vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Trifarotene
Dermatologic Agents