Skip to main content
OpenTrials
Completed

NCT Number: NCT02189629

CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acne Vulgaris Acneiform Eruptions Disease Attributes Facies Pathologic Processes Pathological Conditions, Signs and Symptoms Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Investigational Site, Chomutov, Czechia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CD5789 (trifarotene)

Drug

Primary outcomes

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

    Time frame: From Baseline to Week 52

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

Secondary outcomes

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

    Time frame: From Baseline to Week 52

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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2014
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.