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CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CD5789 (trifarotene)
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 Acne vulgaris, Safety, Face, Trunk

Eligibility Criteria

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

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.

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD5789 (trifarotene) cream

Arm Description

Outcomes

Primary Outcome Measures

Investigator Global Assessment (IGA) Success Rate up to Week 52
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).

Secondary Outcome Measures

Physician Global Assessment (PGA) Success Rate up to Week 52
Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).

Full Information

First Posted
July 11, 2014
Last Updated
November 12, 2019
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02189629
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 23, 2015 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD5789 (trifarotene) cream
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CD5789 (trifarotene)
Primary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) Success Rate up to Week 52
Description
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).
Time Frame
From Baseline to Week 52
Secondary Outcome Measure Information:
Title
Physician Global Assessment (PGA) Success Rate up to Week 52
Description
Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).
Time Frame
From Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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.
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
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Galderma Investigational Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Galderma Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Galderma Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Galderma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Galderma Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Galderma Investigational Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30277
Country
United States
Facility Name
Galderma Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Galderma Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87107
Country
United States
Facility Name
Galderma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Galderma Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Galderma Investigational Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Galderma Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Galderma Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
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
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
110 00
Country
Czechia
Facility Name
Galderma Investigational Site
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Galderma Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Galderma Investigational Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Galderma Investigational Site
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Galderma Investigational Site
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Galderma Investigational Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Galderma Investigational Site
City
Wuppertal
ZIP/Postal Code
42287
Country
Germany
Facility Name
Galderma Investigational Site
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Galderma Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Galderma Investigational Site
City
Pécel
ZIP/Postal Code
2119
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary

12. IPD Sharing Statement

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CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

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