CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Galderma R&D453 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

453

Conditions

Acne Vulgaris

Interventions

CD5789 (trifarotene)DRUG

Eligibility

Sex: ALLMin age: 9 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

Investigator Global Assessment (IGA) Success Rate up to Week 52

Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).

Time frame: From Baseline to Week 52

Secondary Outcomes

Physician Global Assessment (PGA) Success Rate up to Week 52

Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).

Time frame: From Baseline to Week 52

Data from ClinicalTrials.gov

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Galderma Investigational Site

Mobile, Alabama, United States

Galderma Investigational Site

Rogers, Arkansas, United States

Galderma Investigational Site

Sacramento, California, United States

Galderma Investigational Site

San Diego, California, United States

Galderma Investigational Site

Miami, Florida, United States

Galderma Investigational Site

Miramar, Florida, United States

Galderma Investigational Site

Newnan, Georgia, United States

Galderma Investigational Site

Louisville, Kentucky, United States

Galderma Investigational Site

Albuquerque, New Mexico, United States

Galderma Investigational Site

New York, New York, United States

...and 22 more locations