CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: CD5789 (trifarotene) | Phase 3 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: CD5789 (trifarotene) cream |
Drug: CD5789 (trifarotene) |
- 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).
- 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).

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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 |
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.

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
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 |
Study Director: | Kevin Chan | Galderma R&D |
Documents provided by Galderma R&D:
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 |
Acne vulgaris Safety Face Trunk |
Acne Vulgaris Acneiform Eruptions Skin Diseases |
Sebaceous Gland Diseases Trifarotene Dermatologic Agents |