Clinical trial NCT02189629: CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris
Official title: A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Safety
Face
Trunk
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-07-14
Enrollment: 453
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

Detailed description: To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.

Eligibility criteria: Inclusion Criteria:

* The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
* The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.
* Exclusion Criteria:
* The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
* The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
* The Subject has any acne cyst on the face at Screening and at Baseline visits.

Primary outcomes:
measure: Investigator Global Assessment (IGA) Success Rate up to Week 52
timeFrame: From Baseline to Week 52
Secondary outcomes:
measure: Physician Global Assessment (PGA) Success Rate up to Week 52
timeFrame: From Baseline to Week 52
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Galderma Investigational Site
state: Alabama
city: Rogers
country: United States
facility: Galderma Investigational Site
state: Arkansas
city: Sacramento
country: United States
facility: Galderma Investigational Site
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site
state: California
city: Miami
country: United States
facility: Galderma Investigational Site
state: Florida
city: Miramar
country: United States
facility: Galderma Investigational Site
state: Florida
city: Newnan
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Louisville
country: United States
facility: Galderma Investigational Site
state: Kentucky
city: Albuquerque
country: United States
facility: Galderma Investigational Site
state: New Mexico
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: High Point
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Portland
country: United States
facility: Galderma Investigational Site
state: Oregon
city: Knoxville
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Chomutov
country: Czechia
facility: Galderma Investigational Site
city: Hradec Kralove
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: Augsburg
country: Germany
facility: Galderma Investigational Site
city: Berlin
country: Germany
facility: Galderma Investigational Site
city: Berlin
country: Germany
facility: Galderma Investigational Site
city: Dessau
country: Germany
facility: Galderma Investigational Site
city: Mahlow
country: Germany
facility: Galderma Investigational Site
city: Muenster
country: Germany
facility: Galderma Investigational Site
city: Wuppertal
country: Germany
facility: Galderma Investigational Site
city: Balatonfüred
country: Hungary
facility: Galderma Investigational Site
city: Miskolc
country: Hungary
facility: Galderma Investigational Site
city: Pécel
country: Hungary
facility: Galderma Investigational Site
city: Szeged
country: Hungary
facility: Galderma Investigational Site
city: Szekszard
country: Hungary
facility: Galderma Investigational Site
city: Szolnok
country: Hungary
facility: Galderma Investigational Site
Study officials:
affiliation: Galderma R&D
name: Kevin Chan
role: STUDY_DIRECTOR
References: