Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT02556788|
Recruitment Status : Completed
First Posted : September 22, 2015
Results First Posted : September 3, 2019
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: CD5789 (trifarotene) 50µg/g Cream Drug: Placebo Cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||February 7, 2017|
|Actual Study Completion Date :||May 12, 2017|
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.
- 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.
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): NCT02556788
|Study Director:||Kevin Chan||Galderma R&D|