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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CD5789 (trifarotene) 50µg/g Cream
Placebo Cream
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Efficacy, Safety, Acne vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site
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  • Galderma Invetsigational site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CD5789 (Trifarotene) 50µg/g Cream

Placebo Cream

Arm Description

CD5789 (trifarotene) 50µg/g Cream

Placebo Cream

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2015
Last Updated
October 28, 2019
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02556788
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 7, 2017 (Actual)
Study Completion Date
May 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Efficacy, Safety, Acne vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD5789 (Trifarotene) 50µg/g Cream
Arm Type
Experimental
Arm Description
CD5789 (trifarotene) 50µg/g Cream
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Arm Description
Placebo Cream
Intervention Type
Drug
Intervention Name(s)
CD5789 (trifarotene) 50µg/g Cream
Intervention Description
CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Cream
Intervention Description
Placebo cream applied once daily during 12 weeks.
Primary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
Description
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.
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Chan
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Galderma Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Galderma Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Galderma Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Galderma Investigational Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Galderma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Galderma Investigational Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Galderma Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Galderma Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Galderma Investigational Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Galderma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Galderma Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Galderma Investigational Site
City
Corbin
State/Province
Kentucky
ZIP/Postal Code
40701
Country
United States
Facility Name
Galderma Investigational Site
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Galderma Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Galderma Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Galderma Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Galderma Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Galderma Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Galderma Investigational Site
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Galderma Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Galderma Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Galderma Investigational Site
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Galderma Invetsigational site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-8858
Country
United States
Facility Name
Galderma Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-5806
Country
United States
Facility Name
Galderma Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Galderma Investigational Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Galderma Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Galderma Investigational Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Galderma Investigational Site
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Galderma Investigational Site
City
Chomutov
ZIP/Postal Code
430 04
Country
Czechia
Facility Name
Galderma Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Galderma Investigational Site
City
Kutna Hora
ZIP/Postal Code
284 01
Country
Czechia
Facility Name
Galderma Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Galderma Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Galderma Investigational Site
City
Praha 1
ZIP/Postal Code
11 000
Country
Czechia
Facility Name
Galderma Investigational Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Galderma Investigational Site
City
Praha
ZIP/Postal Code
190 11
Country
Czechia
Facility Name
Galderma Investigational Site
City
Budapest
ZIP/Postal Code
1035
Country
Hungary
Facility Name
Galderma Investigational Site
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Galderma Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Galderma Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Galderma Investigational Site
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Galderma Investigational Site
City
Bialystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
Galderma Investigational Site
City
Gdansk
ZIP/Postal Code
80-152
Country
Poland
Facility Name
Galderma Investigational Site
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Galderma Investigational Site
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Galderma Investigational Site
City
Katowice
ZIP/Postal Code
40-036
Country
Poland
Facility Name
Galderma investigational Site
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Galderma Investigational Site
City
Katowice
ZIP/Postal Code
40-851
Country
Poland
Facility Name
Galderma Investigational Site
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Galderma Investigational Site
City
Sochaczew
ZIP/Postal Code
95-500
Country
Poland
Facility Name
Galderma Investigational Site
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Galderma investigational Site
City
Warszawa
ZIP/Postal Code
02-657
Country
Poland
Facility Name
Galderma Investigational Site
City
Warszawa
ZIP/Postal Code
02-758
Country
Poland
Facility Name
Galderma Investigational Site
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Galderma Investigational Site
City
Wroclaw
ZIP/Postal Code
53-658
Country
Poland
Facility Name
Galderma Investigational Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Galderma Investigational Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Galderma Investigational Site
City
Iasi
ZIP/Postal Code
700381
Country
Romania
Facility Name
Galderma Investigational Site
City
Târgu-Mureş
ZIP/Postal Code
540530
Country
Romania
Facility Name
Galderma Investigational Site
City
Krasnodar
ZIP/Postal Code
3500 20
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Lipetsk
ZIP/Postal Code
398035
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Moscow
ZIP/Postal Code
119071
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Moscow
ZIP/Postal Code
121614
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Sr Petersburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
St Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Barcelona
ZIP/Postal Code
08206
Country
Spain
Facility Name
Galderma Investigational Site
City
Esplugues de Llobregat
ZIP/Postal Code
8950
Country
Spain
Facility Name
Galderma Investigational site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Galderma Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Galderma Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Kharkiv
ZIP/Postal Code
61057
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Lviv
ZIP/Postal Code
79049
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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