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

October 28, 2019 updated by: Galderma R&D

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1212

Phase

  • 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

  • Czechia
      • Chomutov, Czechia, 430 04
        • Galderma Investigational Site
      • Hradec Kralove, Czechia, 500 05
        • Galderma Investigational Site
      • Kutna Hora, Czechia, 284 01
        • Galderma Investigational Site
      • Olomouc, Czechia, 775 20
        • Galderma Investigational Site
      • Pardubice, Czechia, 532 03
        • Galderma Investigational Site
      • Praha, Czechia, 190 11
        • Galderma Investigational Site
      • Praha 1, Czechia, 11 000
        • Galderma Investigational Site
      • Praha 1, Czechia, 110 00
        • Galderma Investigational Site
  • Hungary
      • Budapest, Hungary, 1035
        • Galderma Investigational Site
      • Budapest, Hungary, 1089
        • Galderma Investigational Site
      • Debrecen, Hungary, 4032
        • Galderma Investigational Site
      • Miskolc, Hungary, 3529
        • Galderma Investigational Site
      • Pecs, Hungary, 7632
        • Galderma Investigational Site
      • Szeged, Hungary, 6720
        • Galderma Investigational Site
      • Szolnok, Hungary, 5000
        • Galderma Investigational Site
  • Poland
      • Bialystok, Poland, 15-453
        • Galderma Investigational Site
      • Gdansk, Poland, 80-152
        • Galderma Investigational Site
      • Gdansk, Poland, 80-402
        • Galderma Investigational Site
      • Gdansk, Poland, 80-546
        • Galderma Investigational Site
      • Katowice, Poland, 40-036
        • Galderma Investigational Site
      • Katowice, Poland, 40-611
        • Galderma Investigational Site
      • Katowice, Poland, 40-851
        • Galderma Investigational Site
      • Lodz, Poland, 90-242
        • Galderma Investigational Site
      • Sochaczew, Poland, 95-500
        • Galderma Investigational Site
      • Warszawa, Poland, 01-817
        • Galderma Investigational Site
      • Warszawa, Poland, 02-657
        • Galderma Investigational Site
      • Warszawa, Poland, 02-758
        • Galderma Investigational Site
      • Wroclaw, Poland, 51-318
        • Galderma Investigational Site
      • Wroclaw, Poland, 53-658
        • Galderma Investigational Site
  • Romania
      • Brasov, Romania, 500283
        • Galderma Investigational Site
      • Craiova, Romania, 200642
        • Galderma Investigational Site
      • Iasi, Romania, 700381
        • Galderma Investigational Site
      • Târgu-Mureş, Romania, 540530
        • Galderma Investigational Site
  • Russian Federation
      • Krasnodar, Russian Federation, 3500 20
        • Galderma Investigational Site
      • Lipetsk, Russian Federation, 398035
        • Galderma Investigational Site
      • Moscow, Russian Federation, 107076
        • Galderma Investigational Site
      • Moscow, Russian Federation, 119071
        • Galderma Investigational Site
      • Moscow, Russian Federation, 121614
        • Galderma Investigational Site
      • Sr Petersburg, Russian Federation, 194021
        • Galderma Investigational Site
      • St Petersburg, Russian Federation, 194100
        • Galderma Investigational Site
  • Spain
      • Barcelona, Spain, 08206
        • Galderma Investigational Site
      • Esplugues de Llobregat, Spain, 8950
        • Galderma Investigational Site
      • Madrid, Spain, 28009
        • Galderma Investigational Site
      • Valencia, Spain, 46014
        • Galderma Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49044
        • Galderma Investigational Site
      • Dnipropetrovsk, Ukraine, 49074
        • Galderma Investigational Site
      • Ivano-Frankivsk, Ukraine, 76000
        • Galderma Investigational Site
      • Kharkiv, Ukraine, 61057
        • Galderma Investigational Site
      • Kyiv, Ukraine, 01601
        • Galderma Investigational Site
      • Kyiv, Ukraine, 04209
        • Galderma Investigational Site
      • Lviv, Ukraine, 79049
        • Galderma Investigational Site
      • Uzhgorod, Ukraine, 88000
        • Galderma Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Galderma Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Galderma Investigational Site
      • Tucson, Arizona, United States, 85712
        • Galderma Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Galderma Investigational Site
    • California
      • Los Angeles, California, United States, 90036
        • Galderma Investigational Site
      • Murrieta, California, United States, 92562
        • Galderma Investigational Site
      • Santa Ana, California, United States, 92705
        • Galderma Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Galderma Investigational Site
      • Miami, Florida, United States, 33144
        • Galderma Investigational Site
      • Miami Lakes, Florida, United States, 33016
        • Galderma Investigational Site
      • West Palm Beach, Florida, United States, 33406
        • Galderma Investigational Site
    • Kentucky
      • Corbin, Kentucky, United States, 40701
        • Galderma Investigational Site
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Galderma Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Galderma Investigational Site
      • Detroit, Michigan, United States, 48202
        • Galderma Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Galderma Investigational Site
      • Stony Brook, New York, United States, 11790
        • Galderma Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Galderma Investigational Site
    • Pennsylvania
      • Fort Washington, Pennsylvania, United States, 19034
        • Galderma Investigational Site
      • Philadelphia, Pennsylvania, United States, 19103
        • Galderma Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Galderma Investigational Site
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Galderma Investigational Site
    • Texas
      • Austin, Texas, United States, 78759-8858
        • Galderma Invetsigational site
      • Dallas, Texas, United States, 75230-5806
        • Galderma Investigational Site
      • Houston, Texas, United States, 77004
        • Galderma Investigational Site
      • Pflugerville, Texas, United States, 78660
        • Galderma Investigational Site
      • San Antonio, Texas, United States, 78249
        • Galderma Investigational Site
      • Webster, Texas, United States, 77598
        • Galderma Investigational Site
    • Washington
      • Walla Walla, Washington, United States, 99362
        • 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

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Quadruple

Arms and Interventions

Participant Group / 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 during 12 weeks.
Placebo Comparator: Placebo Cream
Drug: Placebo Cream
Placebo cream applied once daily during 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
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.
From Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

November 1, 2015

Primary Completion (Actual)

February 7, 2017

Study Completion (Actual)

May 12, 2017

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.18252

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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