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

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: CD5789 (trifarotene) 50μg/g cream; Drug: Placebo cream

• Registration Number: NCT02566369
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed Description

Clinical Trial for each subject is approximately 14 weeks and are randomized to one of the two treatments for 12 weeks. Subjects must be 9 years of age and older with acne vulgaris.

Study Timeline

• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Study Start: 2015-11-30
• Primary Completion: 2017-11-14
• Study Completion: 2017-11-14
• Disposition First Submitted: 2018-05-15
• Disposition First Submitted QC: 2018-05-17
• Disposition First Posted: 2018-05-18
• Status Verified: 2018-07
• Results First Submitted: 2019-04-18
• Results First Submitted QC: 2019-08-05
• Results First Posted: 2019-08-22
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD5789 (trifarotene) 50μg/g Cream	CD5789 (trifarotene) 50μg/g cream	CD5789 (trifarotene) 50μg/g Cream
Placebo Cream	Placebo cream	Placebo cream

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) Success Rate at Week 12	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.

Trial Locations

Locations (124)

Galderma Investigational Site (8258); 🇺🇸 Mobile, Alabama, United States

Galderma Investigational Site (# 8530); 🇺🇸 Glendale, Arizona, United States

Galderma Investigational Site (# 8511); 🇺🇸 Phoenix, Arizona, United States

Galderma Investigational Site (# 8009); 🇺🇸 Hot Springs, Arkansas, United States

Galderma Investigational Site (# 8355); 🇺🇸 Rogers, Arkansas, United States

Galderma Investigational Site (# 8456); 🇺🇸 Beverly Hills, California, United States

Galderma Investigational site (8578); 🇺🇸 Cerritos, California, United States

Galderma Investigational Site (# 8526); 🇺🇸 Clovis, California, United States

Galderma Investigational Site (8577); 🇺🇸 Encinitas, California, United States

Galderma Investigational Site (# 8224); 🇺🇸 Fremont, California, United States

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