CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

November 12, 2019 updated by: Galderma R&D

A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

453

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
      • Olomouc, Czechia, 775 20
        • Galderma Investigational Site
      • Pardubice, Czechia, 532 03
        • Galderma Investigational Site
      • Praha 1, Czechia, 110 00
        • Galderma Investigational Site
  • Germany
      • 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
        • Galderma Investigational Site
  • Hungary
      • 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
        • Galderma Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Galderma Investigational Site
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Galderma Investigational Site
    • California
      • Sacramento, California, United States, 95819
        • Galderma Investigational Site
      • San Diego, California, United States, 92123
        • Galderma Investigational Site
    • Florida
      • Miami, Florida, United States, 33175
        • Galderma Investigational Site
      • Miramar, Florida, United States, 33027
        • Galderma Investigational Site
    • Georgia
      • Newnan, Georgia, United States, 30277
        • Galderma Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Galderma Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • Galderma Investigational Site
    • New York
      • New York, New York, United States, 10155
        • Galderma Investigational Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Galderma Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Galderma Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Galderma Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • 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

9 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CD5789 (trifarotene) cream
Drug: CD5789 (trifarotene)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From Baseline to Week 52

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 (ACTUAL)

February 23, 2015

Primary Completion (ACTUAL)

February 23, 2017

Study Completion (ACTUAL)

February 23, 2017

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (ESTIMATE)

July 14, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.18250

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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