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Subject Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal 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: NCT03915860
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
Subject Reported Outcomes with use of Trifarotene 50 μg/g Cream in Subjects with Moderate Facial and Truncal Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Trifarotene Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Study to Evaluate Subject Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Trifarotene
Open label, CD5789 (trifarotene) 50μg/g Cream
Drug: Trifarotene
Topical Cream




Primary Outcome Measures :
  1. Trifarotene [ Time Frame: From Baseline to Week 12 ]
    Success rate, defined as the percentage of Subjects who achieve an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement



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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 months 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.
  • 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.ed, 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 Trail.

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): NCT03915860


Locations
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United States, Arkansas
Galderma Investigational Site
Fort Smith, Arkansas, United States, 72916
United States, Massachusetts
Galderma Investigational Site
Beverly, Massachusetts, United States, 01915
United States, New Hampshire
Galderma Investigational Site
Portsmouth, New Hampshire, United States, 03801
United States, Pennsylvania
Galderma Investigational Site
Philadelphia, Pennsylvania, United States, 19103
United States, Texas
Galderma Investigational Site
Austin, Texas, United States, 78759
Galderma Investigational Site
Beaumont, Texas, United States, 77701
Galderma Investigational Site
Irving, Texas, United States, 75062
Galderma Investigational Site
Pflugerville, Texas, United States, 78660
Galderma Investigational Site
Richardson, Texas, United States, 75081
Sponsors and Collaborators
Galderma R&D

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT03915860     History of Changes
Other Study ID Numbers: RD.06.SPR.118295
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Trifarotene
Dermatologic Agents