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CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02189629
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CD5789 (trifarotene) Phase 3

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  (Clinical Trial)
Actual Enrollment : 455 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: CD5789 (trifarotene) cream Drug: CD5789 (trifarotene)



Primary Outcome Measures :
  1. Assessment of Local tolerability and Adverse Event at each visit [ Time Frame: up to 52 weeks ]


Information from the National Library of Medicine

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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 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.

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): NCT02189629


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Sponsors and Collaborators
Galderma R&D

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02189629     History of Changes
Other Study ID Numbers: RD.06.SPR.18250
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Keywords provided by Galderma R&D:
Acne vulgaris
Safety
Face
Trunk

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases