Clinical trial NCT02566369: Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Efficacy
Safety
Acne vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 1208
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Investigator Global Assessment (IGA) Success Rate at Week 12
timeFrame: From Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Galderma Investigational Site (8258)
state: Alabama
city: Glendale
country: United States
facility: Galderma Investigational Site (# 8530)
state: Arizona
city: Phoenix
country: United States
facility: Galderma Investigational Site (# 8511)
state: Arizona
city: Hot Springs
country: United States
facility: Galderma Investigational Site (# 8009)
state: Arkansas
city: Rogers
country: United States
facility: Galderma Investigational Site (# 8355)
state: Arkansas
city: Beverly Hills
country: United States
facility: Galderma Investigational Site (# 8456)
state: California
city: Cerritos
country: United States
facility: Galderma Investigational site (8578)
state: California
city: Clovis
country: United States
facility: Galderma Investigational Site (# 8526)
state: California
city: Encinitas
country: United States
facility: Galderma Investigational Site (8577)
state: California
city: Fremont
country: United States
facility: Galderma Investigational Site (# 8224)
state: California
city: Fullerton
country: United States
facility: Galderma Investigational Site (# 8509)
state: California
city: Huntington Beach
country: United States
facility: Galderma Investigational Site (# 8507)
state: California
city: Newport Beach
country: United States
facility: Galderma Investigational Site (# 8425)
state: California
city: Oceanside
country: United States
facility: Galderma Investigational Site (# 8052)
state: California
city: Santa Ana
country: United States
facility: Galderma Investigational Site (# 8528)
state: California
city: Santa Monica
country: United States
facility: Galderma Investigational Site (# 8160)
state: California
city: Temecula
country: United States
facility: Galderma Investigational Site (# 8443)
state: California
city: Colorado Springs
country: United States
facility: Galderma Investigational Site (8572)
state: Colorado
city: Englewood
country: United States
facility: Galderma Investigational Site (# 8510)
state: Colorado
city: Boynton Beach
country: United States
facility: Galderma Investigational Site (# 8370)
state: Florida
city: Fort Lauderdale
country: United States
facility: Galderma Investigational Site (# 8543)
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site (8143)
state: Florida
city: Miramar
country: United States
facility: Galderma Investigational site (8259)
state: Florida
city: North Miami Beach
country: United States
facility: Galderma Investigational Site (# 8522)
state: Florida
city: Orange Park
country: United States
facility: Galderma Investigational Site (# 8531)
state: Florida
city: Orlando
country: United States
facility: Galderma Investigational Site (8502)
state: Florida
city: Ormond Beach
country: United States
facility: Galderma Investigational Site (#8213)
state: Florida
city: Saint Petersburg
country: United States
facility: Galderma Investigational Site (# 8455)
state: Florida
city: Sanford
country: United States
facility: Galderma Investigational Site (# 8529)
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site (# 8523)
state: Florida
city: West Palm Beach
country: United States
facility: Galderma Investigational Site (# 8126)
state: Florida
city: Snellville
country: United States
facility: Galderma Investigational Site (#8189)
state: Georgia
city: Idaho Falls
country: United States
facility: Galderma Investigational Site (8582)
state: Idaho
city: Arlington Heights
country: United States
facility: Galderma Investigational Site (# 8367)
state: Illinois
city: Chicago
country: United States
facility: Galderma Investigational Site (8191)
state: Illinois
city: Darien
country: United States
facility: Galderma Investigational site (8571)
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Galderma Investigational Site (8575)
state: Illinois
city: Plainfield
country: United States
facility: Galderma Investigational Site (# 8366)
state: Indiana
city: Overland Park
country: United States
facility: Galderma Investigational Site (# 8532)
state: Kansas
city: Louisville
country: United States
facility: Galderma Investigational Site (# 8069)
state: Kentucky
city: Louisville
country: United States
facility: Galderma Investigational Site (8092)
state: Kentucky
city: Owensboro
country: United States
facility: Galderma Investigational Site (8545)
state: Kentucky
city: Monroe
country: United States
facility: Galderma Investigational Site (8457)
state: Louisiana
city: New Orleans
country: United States
facility: Galderma Investigational site (8580)
state: Louisiana
city: Glenn Dale
country: United States
facility: Galderma Investigational Site (# 8012)
state: Maryland
city: Rockville
country: United States
facility: Galderma Investigational Site (# 8525)
state: Maryland
city: Quincy
country: United States
facility: Galderma Investigational Site (# 8541)
state: Massachusetts
city: Bay City
country: United States
facility: Galderma Investigational Site (#8512)
state: Michigan
city: Clarkston
country: United States
facility: Galderma Investigational Site (8574)
state: Michigan
city: Clinton Township
country: United States
facility: Galderma Investigational Site (#8033)
state: Michigan
city: Fort Gratiot
country: United States
facility: Galderma Investigational Site (8129)
state: Michigan
city: Warren
country: United States
facility: Galderma Investigational Site (# 8226)
state: Michigan
city: Saint Joseph
country: United States
facility: Galderma Investigational Site (# 8521)
state: Missouri
city: Saint Louis
country: United States
facility: Galderma Investigational Site (#8027)
state: Missouri
city: Lincoln
country: United States
facility: Galderma Investigational Site (# 8544)
state: Nebraska
city: Las Vegas
country: United States
facility: Galderma Investigational Site (# 8108)
state: Nevada
city: Newington
country: United States
facility: Galderma Investigational Site (#8420)
state: New Hampshire
city: Hackensack
country: United States
facility: Galderma Investigational Site (# 8506)
state: New Jersey
city: Brooklyn
country: United States
facility: Galderma Investigational Site (#8500)
state: New York
city: East Setauket
country: United States
facility: Galderma Investigational Site (8524)
state: New York
city: New York
country: United States
facility: Galderma Investigational Site (8568)
state: New York
city: New York
country: United States
facility: Galderma Investigational Site (8585)
state: New York
city: New York
country: United States
facility: Galderma Investigational Site (8279)
state: New York
city: Charlotte
country: United States
facility: Galderma Investigational Site (8566)
state: North Carolina
city: Hickory
country: United States
facility: Galderma Investigational Site (#8514)
state: North Carolina
city: Beachwood
country: United States
facility: Galderma Investigational Site (# 8195)
state: Ohio
city: Cincinnati
country: United States
facility: Galderma Investigational Site (# 8016)
state: Ohio
city: Dublin
country: United States
facility: Galderma Investigational site (8595)
state: Ohio
city: Hershey
country: United States
facility: Galderma Investigational Site (8188)
state: Pennsylvania
city: Yardley
country: United States
facility: Galderma Investigational site (8353)
state: Pennsylvania
city: Charleston
country: United States
facility: Galderma Investigational Site (# 8369)
state: South Carolina
city: Knoxville
country: United States
facility: Galderma Investigational Site (# 8117)
state: Tennessee
city: Nashville
country: United States
facility: Galderma Investigational Site (# 8515)
state: Tennessee
city: Arlington
country: United States
facility: Galderma Investigational Site (# 8542)
state: Texas
city: Austin
country: United States
facility: Galderma Investigational Site (#8513)
state: Texas
city: Beaumont
country: United States
facility: Galderma Investigational site (8579)
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site (# 8245)
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site (8183)
state: Texas
city: Katy
country: United States
facility: Galderma Investigational site (8576)
state: Texas
city: Murphy
country: United States
facility: Galderma Investigational Site (8583)
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site (8567)
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational site (8433)
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational site (8329)
state: Texas
city: Layton
country: United States
facility: Galderma Investigational site (8106)
state: Utah
city: Salt Lake City
country: United States
facility: Galderma Investigational Site (# 8214)
state: Utah
city: Seattle
country: United States
facility: Galderma Investigational Site (# 8351)
state: Washington
city: Calgary
country: Canada
facility: Galderma Investigational Site (# 8215)
state: Alberta
city: Surrey
country: Canada
facility: Galderma Investigational site (8161)
state: British Columbia
city: Winnipeg
country: Canada
facility: Galderma Investigational Site (# 8154)
state: Manitoba
city: Barrie
country: Canada
facility: Galderma Investigational Site (8586)
state: Ontario
city: Hamilton
country: Canada
facility: Galderma Investigational Site (# 8038)
state: Ontario
city: London
country: Canada
facility: Galderma Investigational Site (# 8426)
state: Ontario
city: Markham
country: Canada
facility: Galderma Investigational Site (# 8026)
state: Ontario
city: North Bay
country: Canada
facility: Galderma Investigational Site (# 8135)
state: Ontario
city: Oakville
country: Canada
facility: Galderma Investigational Site (# 8168)
state: Ontario
city: Peterborough
country: Canada
facility: Galderma Investigational Site (# 8340)
state: Ontario
city: Richmond Hill
country: Canada
facility: Galderma Investigational Site (# 8338)
state: Ontario
city: Waterloo
country: Canada
facility: Galderma Investigational Site (8001)
state: Ontario
city: Windsor
country: Canada
facility: Galderma Investigational Site (# 8060)
state: Ontario
city: Augsburg
country: Germany
facility: Galderma Investigational Site (5566)
city: Berlin
country: Germany
facility: Galderma Investigational Site (5604)
city: Berlin
country: Germany
facility: Galderma Investigational Site (5815)
city: Darmstadt
country: Germany
facility: Galderma Investigational Site (5750)
city: Dessau
country: Germany
facility: Galderma Investigational Site (5572)
city: Dresden
country: Germany
facility: Galderma Investigational Site (5204)
city: Dresden
country: Germany
facility: Galderma Investigational Site (5434)
city: Eberstadt
country: Germany
facility: Galderma Investigational Site (5146)
city: Hamburg
country: Germany
facility: Galderma Investigational Site (5838)
city: Langenau
country: Germany
facility: Galderma Investigational Site (5635)
city: Mainz
country: Germany
facility: Galderma Investigational Site (5543)
city: Münster
country: Germany
facility: Galderma Investigational Site (5307)
city: Balatonfüred
country: Hungary
facility: Galderma Investigational Site (5802)
city: Budapest
country: Hungary
facility: Galderma Investigational Site (5567)
city: Budapest
country: Hungary
facility: Galderma Investigational Site (5812)
city: Cegléd
country: Hungary
facility: Galderma Investigational Site (5685)
city: Nyíregyháza
country: Hungary
facility: Galderma Investigational Site (5254)
city: Pécel
country: Hungary
facility: Galderma Investigational Site (5811)
city: Püspökladány
country: Hungary
facility: Galderma Investigational Site (5263)
city: Szeged
country: Hungary
facility: Galderma Investigational Site (5237)
city: Szekszàrd
country: Hungary
facility: Galderma Investigational Site (5767)
city: Aibonito
country: Puerto Rico
facility: Galderma Investigational Site (8592)
city: Caguas
country: Puerto Rico
facility: Galderma Investigational Site (8594)
city: Carolina
country: Puerto Rico
facility: Galderma Investigational site (8100)
city: San Juan
country: Puerto Rico
facility: Galderma Investigational Site (8593)
Study officials:
affiliation: Windsor Clinical Research
name: Jerry Tan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité Universitätsmedizin
name: Ulrike Blume-Peytavi, MD
role: PRINCIPAL_INVESTIGATOR
References: