Status:
COMPLETED
CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
9+ years
Phase:
PHASE3
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.
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 objecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2017
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT02189629
Start Date
February 23 2015
End Date
February 23 2017
Last Update
November 14 2019
Active Locations (32)
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1
Galderma Investigational Site
Mobile, Alabama, United States, 36608
2
Galderma Investigational Site
Rogers, Arkansas, United States, 72758
3
Galderma Investigational Site
Sacramento, California, United States, 95819
4
Galderma Investigational Site
San Diego, California, United States, 92123