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OpenTrials
Completed

NCT Number: NCT02556788

Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris

Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.

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Key information

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Investigational Site, Chomutov, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject is a male or female, 9 years of age or older, at Screening visit.
  • The Subject has moderate acne at Screening and Baseline.
  • The subject is a female of non childbearing potential
  • The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.

Exclusion criteria

  • The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
  • The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial.
  • The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.)
  • The subject is unwilling to refrain from use of prohibited medication during the clinical trial

Treatment and study plan

CD5789 (trifarotene) 50µg/g Cream

Drug

CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.

placebo cream

Drug

Placebo cream applied once daily during 12 weeks.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2015
Registry last updated
Nov 12, 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.

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