Clinical trial NCT02556788: Double-Blind 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: 2015-09-22
Enrollment: 1212
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.


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) Score of 1 (Almost Clear) or 0 (Clear)
timeFrame: From Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Galderma Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Galderma Investigational Site
state: Arizona
city: Fort Smith
country: United States
facility: Galderma Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Galderma Investigational Site
state: California
city: Murrieta
country: United States
facility: Galderma Investigational Site
state: California
city: Santa Ana
country: United States
facility: Galderma Investigational Site
state: California
city: Aventura
country: United States
facility: Galderma Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Galderma Investigational Site
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Galderma Investigational Site
state: Florida
city: Corbin
country: United States
facility: Galderma Investigational Site
state: Kentucky
city: Beverly
country: United States
facility: Galderma Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Brooklyn
country: United States
facility: Galderma Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Galderma Investigational Site
state: New York
city: Wilmington
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Fort Washington
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Galderma Investigational Site
state: South Carolina
city: Goodlettsville
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Galderma Invetsigational site
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site
state: Texas
city: Pflugerville
country: United States
facility: Galderma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site
state: Texas
city: Webster
country: United States
facility: Galderma Investigational Site
state: Texas
city: Walla Walla
country: United States
facility: Galderma Investigational Site
state: Washington
city: Chomutov
country: Czechia
facility: Galderma Investigational Site
city: Hradec Kralove
country: Czechia
facility: Galderma Investigational Site
city: Kutna Hora
country: Czechia
facility: Galderma Investigational Site
city: Olomouc
country: Czechia
facility: Galderma Investigational Site
city: Pardubice
country: Czechia
facility: Galderma Investigational Site
city: Praha 1
country: Czechia
facility: Galderma Investigational Site
city: Praha 1
country: Czechia
facility: Galderma Investigational Site
city: Praha
country: Czechia
facility: Galderma Investigational Site
city: Budapest
country: Hungary
facility: Galderma Investigational Site
city: Budapest
country: Hungary
facility: Galderma Investigational Site
city: Debrecen
country: Hungary
facility: Galderma Investigational Site
city: Miskolc
country: Hungary
facility: Galderma Investigational Site
city: Pecs
country: Hungary
facility: Galderma Investigational Site
city: Szeged
country: Hungary
facility: Galderma Investigational Site
city: Szolnok
country: Hungary
facility: Galderma Investigational Site
city: Bialystok
country: Poland
facility: Galderma Investigational Site
city: Gdansk
country: Poland
facility: Galderma Investigational Site
city: Gdansk
country: Poland
facility: Galderma Investigational Site
city: Gdansk
country: Poland
facility: Galderma Investigational Site
city: Katowice
country: Poland
facility: Galderma Investigational Site
city: Katowice
country: Poland
facility: Galderma investigational Site
city: Katowice
country: Poland
facility: Galderma Investigational Site
city: Lodz
country: Poland
facility: Galderma Investigational Site
city: Sochaczew
country: Poland
facility: Galderma Investigational Site
city: Warszawa
country: Poland
facility: Galderma Investigational Site
city: Warszawa
country: Poland
facility: Galderma investigational Site
city: Warszawa
country: Poland
facility: Galderma Investigational Site
city: Wroclaw
country: Poland
facility: Galderma Investigational Site
city: Wroclaw
country: Poland
facility: Galderma Investigational Site
city: Brasov
country: Romania
facility: Galderma Investigational Site
city: Craiova
country: Romania
facility: Galderma Investigational Site
city: Iasi
country: Romania
facility: Galderma Investigational Site
city: Târgu-Mureş
country: Romania
facility: Galderma Investigational Site
city: Krasnodar
country: Russian Federation
facility: Galderma Investigational Site
city: Lipetsk
country: Russian Federation
facility: Galderma Investigational Site
city: Moscow
country: Russian Federation
facility: Galderma Investigational Site
city: Moscow
country: Russian Federation
facility: Galderma Investigational Site
city: Moscow
country: Russian Federation
facility: Galderma Investigational Site
city: Sr Petersburg
country: Russian Federation
facility: Galderma Investigational Site
city: St Petersburg
country: Russian Federation
facility: Galderma Investigational Site
city: Barcelona
country: Spain
facility: Galderma Investigational Site
city: Esplugues de Llobregat
country: Spain
facility: Galderma Investigational Site
city: Madrid
country: Spain
facility: Galderma Investigational site
city: Valencia
country: Spain
facility: Galderma Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Galderma Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Galderma Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Galderma Investigational Site
city: Kharkiv
country: Ukraine
facility: Galderma Investigational Site
city: Kyiv
country: Ukraine
facility: Galderma Investigational Site
city: Kyiv
country: Ukraine
facility: Galderma Investigational Site
city: Lviv
country: Ukraine
facility: Galderma Investigational Site
city: Uzhgorod
country: Ukraine
facility: Galderma Investigational Site
Study officials:
affiliation: Galderma R&D
name: Kevin Chan
role: STUDY_DIRECTOR
References: