Double-Blind 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: NCT02556788
• Other study ID #: RD.06.SPR.18252
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: May 12, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1212
• Est. completion date: May 12, 2017
• Est. primary completion date: February 7, 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 during 12 weeks.
• Placebo Cream
Placebo cream applied once daily during 12 weeks.

Locations

Country	Name	City	State
Czechia	Galderma Investigational Site	Chomutov
Czechia	Galderma Investigational Site	Hradec Kralove
Czechia	Galderma Investigational Site	Kutna Hora
Czechia	Galderma Investigational Site	Olomouc
Czechia	Galderma Investigational Site	Pardubice
Czechia	Galderma Investigational Site	Praha
Czechia	Galderma Investigational Site	Praha 1
Czechia	Galderma Investigational Site	Praha 1
Hungary	Galderma Investigational Site	Budapest
Hungary	Galderma Investigational Site	Budapest
Hungary	Galderma Investigational Site	Debrecen
Hungary	Galderma Investigational Site	Miskolc
Hungary	Galderma Investigational Site	Pecs
Hungary	Galderma Investigational Site	Szeged
Hungary	Galderma Investigational Site	Szolnok
Poland	Galderma Investigational Site	Bialystok
Poland	Galderma Investigational Site	Gdansk
Poland	Galderma Investigational Site	Gdansk
Poland	Galderma Investigational Site	Gdansk
Poland	Galderma Investigational Site	Katowice
Poland	Galderma investigational Site	Katowice
Poland	Galderma Investigational Site	Katowice
Poland	Galderma Investigational Site	Lodz
Poland	Galderma Investigational Site	Sochaczew
Poland	Galderma Investigational Site	Warszawa
Poland	Galderma investigational Site	Warszawa
Poland	Galderma Investigational Site	Warszawa
Poland	Galderma Investigational Site	Wroclaw
Poland	Galderma Investigational Site	Wroclaw
Romania	Galderma Investigational Site	Brasov
Romania	Galderma Investigational Site	Craiova
Romania	Galderma Investigational Site	Iasi
Romania	Galderma Investigational Site	Târgu-Mures
Russian Federation	Galderma Investigational Site	Krasnodar
Russian Federation	Galderma Investigational Site	Lipetsk
Russian Federation	Galderma Investigational Site	Moscow
Russian Federation	Galderma Investigational Site	Moscow
Russian Federation	Galderma Investigational Site	Moscow
Russian Federation	Galderma Investigational Site	Sr Petersburg
Russian Federation	Galderma Investigational Site	St Petersburg
Spain	Galderma Investigational Site	Barcelona
Spain	Galderma Investigational Site	Esplugues de Llobregat
Spain	Galderma Investigational site	Madrid
Spain	Galderma Investigational Site	Valencia
Ukraine	Galderma Investigational Site	Dnipropetrovsk
Ukraine	Galderma Investigational Site	Dnipropetrovsk
Ukraine	Galderma Investigational Site	Ivano-Frankivsk
Ukraine	Galderma Investigational Site	Kharkiv
Ukraine	Galderma Investigational Site	Kyiv
Ukraine	Galderma Investigational Site	Kyiv
Ukraine	Galderma Investigational Site	Lviv
Ukraine	Galderma Investigational Site	Uzhgorod
United States	Galderma Investigational Site	Ann Arbor	Michigan
United States	Galderma Invetsigational site	Austin	Texas
United States	Galderma Investigational Site	Aventura	Florida
United States	Galderma Investigational Site	Beverly	Massachusetts
United States	Galderma Investigational Site	Birmingham	Alabama
United States	Galderma Investigational Site	Brooklyn	New York
United States	Galderma Investigational Site	Corbin	Kentucky
United States	Galderma Investigational Site	Dallas	Texas
United States	Galderma Investigational Site	Detroit	Michigan
United States	Galderma Investigational Site	Fort Smith	Arkansas
United States	Galderma Investigational Site	Fort Washington	Pennsylvania
United States	Galderma Investigational Site	Goodlettsville	Tennessee
United States	Galderma Investigational Site	Greer	South Carolina
United States	Galderma Investigational Site	Houston	Texas
United States	Galderma Investigational Site	Los Angeles	California
United States	Galderma Investigational Site	Miami	Florida
United States	Galderma Investigational Site	Miami Lakes	Florida
United States	Galderma Investigational Site	Murrieta	California
United States	Galderma Investigational Site	Pflugerville	Texas
United States	Galderma Investigational Site	Philadelphia	Pennsylvania
United States	Galderma Investigational Site	Phoenix	Arizona
United States	Galderma Investigational Site	San Antonio	Texas
United States	Galderma Investigational Site	Santa Ana	California
United States	Galderma Investigational Site	Stony Brook	New York
United States	Galderma Investigational Site	Tucson	Arizona
United States	Galderma Investigational Site	Walla Walla	Washington
United States	Galderma Investigational Site	Webster	Texas
United States	Galderma Investigational Site	West Palm Beach	Florida
United States	Galderma Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)	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