CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: CD5789 (trifarotene)

• Registration Number: NCT02189629
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Study Start: 2015-02-23
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Disposition First Submitted: 2018-05-15
• Disposition First Submitted QC: 2018-05-17
• Disposition First Posted: 2018-05-18
• Results First Submitted: 2019-04-18
• Results First Submitted QC: 2019-08-28
• Results First Posted: 2019-09-17
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD5789 (trifarotene) cream	CD5789 (trifarotene)	-

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) Success Rate up to Week 52	From Baseline to Week 52	Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).

Secondary Outcome Measures

Name	Time	Method
Physician Global Assessment (PGA) Success Rate up to Week 52	From Baseline to Week 52	Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).

Trial Locations

Locations (2)

Galderma Investigational Site; 🇭🇺 Szolnok, Hungary

Galderma Investigational site; 🇨🇿 Praha 1, Czechia