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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT02566369

Run by

Galderma R&D

People needed

1208

Starts

2015-11-30

Expected to finish

2017-11-14

Last updated by the study team

2019-11-12

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Galderma Investigational Site (# 8509) — Fullerton, California, United States
• Galderma Investigational Site (# 8507) — Huntington Beach, California, United States
• Galderma Investigational Site (# 8425) — Newport Beach, California, United States
• Galderma Investigational Site (# 8052) — Oceanside, California, United States
• Galderma Investigational Site (# 8528) — Santa Ana, California, United States
• Galderma Investigational Site (# 8160) — Santa Monica, California, United States
• Galderma Investigational Site (# 8443) — Temecula, California, United States
• Galderma Investigational Site (8572) — Colorado Springs, Colorado, United States
• Galderma Investigational Site (# 8510) — Englewood, Colorado, United States
• Galderma Investigational Site (# 8370) — Boynton Beach, Florida, United States
• Galderma Investigational Site (# 8543) — Fort Lauderdale, Florida, United States
• Galderma Investigational Site (8143) — Miami, Florida, United States
• Galderma Investigational site (8259) — Miramar, Florida, United States
• Galderma Investigational Site (# 8522) — North Miami Beach, Florida, United States
• Galderma Investigational Site (# 8531) — Orange Park, Florida, United States
• Galderma Investigational Site (8258) — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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