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

Acne Vulgaris Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566369
• Other study ID #: RD.06.SPR.18251
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2015
• Est. completion date: November 14, 2017

Study information

• Verified date: July 2018
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1208
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CD5789 (trifarotene) 50µg/g cream
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
• Placebo cream
Placebo cream applied once daily for 12 weeks

Locations

Country	Name	City	State
Canada	Galderma Investigational Site (8586)	Barrie	Ontario
Canada	Galderma Investigational Site (# 8215)	Calgary	Alberta
Canada	Galderma Investigational Site (# 8038)	Hamilton	Ontario
Canada	Galderma Investigational Site (# 8426)	London	Ontario
Canada	Galderma Investigational Site (# 8026)	Markham	Ontario
Canada	Galderma Investigational Site (# 8135)	North Bay	Ontario
Canada	Galderma Investigational Site (# 8168)	Oakville	Ontario
Canada	Galderma Investigational Site (# 8340)	Peterborough	Ontario
Canada	Galderma Investigational Site (# 8338)	Richmond Hill	Ontario
Canada	Galderma Investigational site (8161)	Surrey	British Columbia
Canada	Galderma Investigational Site (8001)	Waterloo	Ontario
Canada	Galderma Investigational Site (# 8060)	Windsor	Ontario
Canada	Galderma Investigational Site (# 8154)	Winnipeg	Manitoba
Germany	Galderma Investigational Site (5566)	Augsburg
Germany	Galderma Investigational Site (5604)	Berlin
Germany	Galderma Investigational Site (5815)	Berlin
Germany	Galderma Investigational Site (5750)	Darmstadt
Germany	Galderma Investigational Site (5572)	Dessau
Germany	Galderma Investigational Site (5204)	Dresden
Germany	Galderma Investigational Site (5434)	Dresden
Germany	Galderma Investigational Site (5146)	Eberstadt
Germany	Galderma Investigational Site (5838)	Hamburg
Germany	Galderma Investigational Site (5635)	Langenau
Germany	Galderma Investigational Site (5543)	Mainz
Germany	Galderma Investigational Site (5307)	Münster
Hungary	Galderma Investigational Site (5802)	Balatonfüred
Hungary	Galderma Investigational Site (5567)	Budapest
Hungary	Galderma Investigational Site (5812)	Budapest
Hungary	Galderma Investigational Site (5685)	Cegléd
Hungary	Galderma Investigational Site (5254)	Nyíregyháza
Hungary	Galderma Investigational Site (5811)	Pécel
Hungary	Galderma Investigational Site (5263)	Püspökladány
Hungary	Galderma Investigational Site (5237)	Szeged
Hungary	Galderma Investigational Site (5767)	Szekszàrd
Puerto Rico	Galderma Investigational Site (8592)	Aibonito
Puerto Rico	Galderma Investigational Site (8594)	Caguas
Puerto Rico	Galderma Investigational site (8100)	Carolina
Puerto Rico	Galderma Investigational Site (8593)	San Juan
United States	Galderma Investigational Site (# 8542)	Arlington	Texas
United States	Galderma Investigational Site (# 8367)	Arlington Heights	Illinois
United States	Galderma Investigational Site (#8513)	Austin	Texas
United States	Galderma Investigational Site (#8512)	Bay City	Michigan
United States	Galderma Investigational Site (# 8195)	Beachwood	Ohio
United States	Galderma Investigational site (8579)	Beaumont	Texas
United States	Galderma Investigational Site (# 8456)	Beverly Hills	California
United States	Galderma Investigational Site (# 8370)	Boynton Beach	Florida
United States	Galderma Investigational Site (#8500)	Brooklyn	New York
United States	Galderma Investigational site (8578)	Cerritos	California
United States	Galderma Investigational Site (# 8369)	Charleston	South Carolina
United States	Galderma Investigational Site (8566)	Charlotte	North Carolina
United States	Galderma Investigational Site (8191)	Chicago	Illinois
United States	Galderma Investigational Site (# 8016)	Cincinnati	Ohio
United States	Galderma Investigational Site (8574)	Clarkston	Michigan
United States	Galderma Investigational Site (#8033)	Clinton Township	Michigan
United States	Galderma Investigational Site (# 8526)	Clovis	California
United States	Galderma Investigational Site (8572)	Colorado Springs	Colorado
United States	Galderma Investigational Site (# 8245)	Dallas	Texas
United States	Galderma Investigational site (8571)	Darien	Illinois
United States	Galderma Investigational site (8595)	Dublin	Ohio
United States	Galderma Investigational Site (8524)	East Setauket	New York
United States	Galderma Investigational Site (8577)	Encinitas	California
United States	Galderma Investigational Site (# 8510)	Englewood	Colorado
United States	Galderma Investigational Site (8129)	Fort Gratiot	Michigan
United States	Galderma Investigational Site (# 8543)	Fort Lauderdale	Florida
United States	Galderma Investigational Site (# 8224)	Fremont	California
United States	Galderma Investigational Site (# 8509)	Fullerton	California
United States	Galderma Investigational Site (# 8530)	Glendale	Arizona
United States	Galderma Investigational Site (# 8012)	Glenn Dale	Maryland
United States	Galderma Investigational Site (# 8506)	Hackensack	New Jersey
United States	Galderma Investigational Site (8188)	Hershey	Pennsylvania
United States	Galderma Investigational Site (#8514)	Hickory	North Carolina
United States	Galderma Investigational Site (# 8009)	Hot Springs	Arkansas
United States	Galderma Investigational Site (8183)	Houston	Texas
United States	Galderma Investigational Site (# 8507)	Huntington Beach	California
United States	Galderma Investigational Site (8582)	Idaho Falls	Idaho
United States	Galderma Investigational site (8576)	Katy	Texas
United States	Galderma Investigational Site (# 8117)	Knoxville	Tennessee
United States	Galderma Investigational Site (# 8108)	Las Vegas	Nevada
United States	Galderma Investigational site (8106)	Layton	Utah
United States	Galderma Investigational Site (# 8544)	Lincoln	Nebraska
United States	Galderma Investigational Site (# 8069)	Louisville	Kentucky
United States	Galderma Investigational Site (8092)	Louisville	Kentucky
United States	Galderma Investigational Site (8143)	Miami	Florida
United States	Galderma Investigational site (8259)	Miramar	Florida
United States	Galderma Investigational Site (8258)	Mobile	Alabama
United States	Galderma Investigational Site (8457)	Monroe	Louisiana
United States	Galderma Investigational Site (8583)	Murphy	Texas
United States	Galderma Investigational Site (# 8515)	Nashville	Tennessee
United States	Galderma Investigational site (8580)	New Orleans	Louisiana
United States	Galderma Investigational Site (8279)	New York	New York
United States	Galderma Investigational Site (8568)	New York	New York
United States	Galderma Investigational Site (8585)	New York	New York
United States	Galderma Investigational Site (#8420)	Newington	New Hampshire
United States	Galderma Investigational Site (# 8425)	Newport Beach	California
United States	Galderma Investigational Site (# 8522)	North Miami Beach	Florida
United States	Galderma Investigational Site (8575)	Oakbrook Terrace	Illinois
United States	Galderma Investigational Site (# 8052)	Oceanside	California
United States	Galderma Investigational Site (# 8531)	Orange Park	Florida
United States	Galderma Investigational Site (8502)	Orlando	Florida
United States	Galderma Investigational Site (#8213)	Ormond Beach	Florida
United States	Galderma Investigational Site (# 8532)	Overland Park	Kansas
United States	Galderma Investigational Site (8545)	Owensboro	Kentucky
United States	Galderma Investigational Site (# 8511)	Phoenix	Arizona
United States	Galderma Investigational Site (# 8366)	Plainfield	Indiana
United States	Galderma Investigational Site (# 8541)	Quincy	Massachusetts
United States	Galderma Investigational Site (# 8525)	Rockville	Maryland
United States	Galderma Investigational Site (# 8355)	Rogers	Arkansas
United States	Galderma Investigational Site (# 8521)	Saint Joseph	Missouri
United States	Galderma Investigational Site (#8027)	Saint Louis	Missouri
United States	Galderma Investigational Site (# 8455)	Saint Petersburg	Florida
United States	Galderma Investigational Site (# 8214)	Salt Lake City	Utah
United States	Galderma Investigational site (8329)	San Antonio	Texas
United States	Galderma Investigational site (8433)	San Antonio	Texas
United States	Galderma Investigational Site (8567)	San Antonio	Texas
United States	Galderma Investigational Site (# 8529)	Sanford	Florida
United States	Galderma Investigational Site (# 8528)	Santa Ana	California
United States	Galderma Investigational Site (# 8160)	Santa Monica	California
United States	Galderma Investigational Site (# 8351)	Seattle	Washington
United States	Galderma Investigational Site (#8189)	Snellville	Georgia
United States	Galderma Investigational Site (# 8523)	Tampa	Florida
United States	Galderma Investigational Site (# 8443)	Temecula	California
United States	Galderma Investigational Site (# 8226)	Warren	Michigan
United States	Galderma Investigational Site (# 8126)	West Palm Beach	Florida
United States	Galderma Investigational site (8353)	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hungary,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment (IGA) Success Rate at 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.	From Baseline to Week 12