CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris
Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT02189629
Collaborator
(none)
453
32
1
24
14.2
0.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
453 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
Actual Study Start Date
:
Feb 23, 2015
Actual Primary Completion Date
:
Feb 23, 2017
Actual Study Completion Date
:
Feb 23, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CD5789 (trifarotene) cream
|
Drug: CD5789 (trifarotene)
|
Outcome Measures
Primary Outcome Measures
- Investigator Global Assessment (IGA) Success Rate up to Week 52 [From Baseline 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 [From Baseline to Week 52]
Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).
Eligibility Criteria
Criteria
Ages Eligible for Study:
9 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Galderma Investigational Site | Mobile | Alabama | United States | 36608 |
| 2 | Galderma Investigational Site | Rogers | Arkansas | United States | 72758 |
| 3 | Galderma Investigational Site | Sacramento | California | United States | 95819 |
| 4 | Galderma Investigational Site | San Diego | California | United States | 92123 |
| 5 | Galderma Investigational Site | Miami | Florida | United States | 33175 |
| 6 | Galderma Investigational Site | Miramar | Florida | United States | 33027 |
| 7 | Galderma Investigational Site | Newnan | Georgia | United States | 30277 |
| 8 | Galderma Investigational Site | Louisville | Kentucky | United States | 40241 |
| 9 | Galderma Investigational Site | Albuquerque | New Mexico | United States | 87107 |
| 10 | Galderma Investigational Site | New York | New York | United States | 10155 |
| 11 | Galderma Investigational Site | High Point | North Carolina | United States | 27262 |
| 12 | Galderma Investigational Site | Beachwood | Ohio | United States | 44122 |
| 13 | Galderma Investigational Site | Portland | Oregon | United States | 97210 |
| 14 | Galderma Investigational Site | Knoxville | Tennessee | United States | 37922 |
| 15 | Galderma Investigational Site | Chomutov | Czechia | 430 04 | |
| 16 | Galderma Investigational site | Hradec Kralove | Czechia | 500 05 | |
| 17 | Galderma Investigational Site | Olomouc | Czechia | 775 20 | |
| 18 | Galderma Investigational Site | Pardubice | Czechia | 532 03 | |
| 19 | Galderma Investigational site | Praha 1 | Czechia | 110 00 | |
| 20 | Galderma Investigational Site | Augsburg | Germany | 86179 | |
| 21 | Galderma Investigational Site | Berlin | Germany | 10117 | |
| 22 | Galderma Investigational Site | Berlin | Germany | 13507 | |
| 23 | Galderma Investigational Site | Dessau | Germany | 06847 | |
| 24 | Galderma Investigational Site | Mahlow | Germany | 15831 | |
| 25 | Galderma Investigational Site | Muenster | Germany | 48149 | |
| 26 | Galderma Investigational Site | Wuppertal | Germany | 42287 | |
| 27 | Galderma Investigational Site | Balatonfüred | Hungary | 8230 | |
| 28 | Galderma Investigational Site | Miskolc | Hungary | 3529 | |
| 29 | Galderma Investigational Site | Pécel | Hungary | 2119 | |
| 30 | Galderma Investigational Site | Szeged | Hungary | 6720 | |
| 31 | Galderma Investigational Site | Szekszard | Hungary | 7100 | |
| 32 | Galderma Investigational Site | Szolnok | Hungary | 5000 |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Study Director: Kevin Chan, Galderma R&D
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT02189629
Other Study ID Numbers:
- RD.06.SPR.18250
First Posted:
Jul 14, 2014
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019
Keywords provided by Galderma R&D
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CD5789 Cream |
|---|---|
| Arm/Group Description | CD5789 Trifarotene 50 microgram/gram cream |
| Period Title: Overall Study | |
| STARTED | 453 |
| COMPLETED | 348 |
| NOT COMPLETED | 105 |
Baseline Characteristics
| Arm/Group Title | CD5789 Cream |
|---|---|
| Arm/Group Description | CD5789 Trifarotene 50 microgram/gram |
| Overall Participants | 453 |
| Age (Count of Participants) | |
| <=18 years |
286
63.1%
|
| Between 18 and 65 years |
167
36.9%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
226
49.9%
|
| Male |
227
50.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
47
10.4%
|
| Not Hispanic or Latino |
406
89.6%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
0.2%
|
| Asian |
3
0.7%
|
| Native Hawaiian or Other Pacific Islander |
3
0.7%
|
| Black or African American |
12
2.6%
|
| White |
432
95.4%
|
| More than one race |
2
0.4%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| Hungary |
91
20.1%
|
| United States |
163
36%
|
| Czechia |
104
23%
|
| Germany |
95
21%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram. |
| Arm/Group Title | CD5789 Cream |
|---|---|
| Arm/Group Description | CD5789 Trifarotene 50 microgram/gram |
| Measure Participants | 453 |
| Count of Participants [Participants] |
453
100%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram |
| Arm/Group Title | CD5789 Cream |
|---|---|
| Arm/Group Description | CD5789 Trifarotene 50 microgram/gram |
| Measure Participants | 453 |
| Count of Participants [Participants] |
453
100%
|
Adverse Events
| Time Frame | Over 52 Weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | CD5789 Cream | |
| Arm/Group Description | CD5789 Trifarotene 50 microgram/gram | |
All Cause Mortality |
||
| CD5789 Cream | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/453 (0%) | |
Serious Adverse Events |
||
| CD5789 Cream | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/453 (2.2%) | |
| Gastrointestinal disorders | ||
| Crohn's Disease | 1/453 (0.2%) | |
| Umbilical Hernia | 1/453 (0.2%) | |
| Infections and infestations | ||
| Appendicitis | 1/453 (0.2%) | |
| Pyelonephritis Acute | 1/453 (0.2%) | |
| Injury, poisoning and procedural complications | ||
| Post procedural haemorrhage | 1/453 (0.2%) | |
| Investigations | ||
| Liver function test abnormal | 1/453 (0.2%) | |
| Nervous system disorders | ||
| Complex partial seizures | 1/453 (0.2%) | |
| Complex regional Pain syndrome | 1/453 (0.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Nasal septum deviation | 1/453 (0.2%) | |
| Tonsillar hypertrophy | 1/453 (0.2%) | |
Other (Not Including Serious) Adverse Events |
||
| CD5789 Cream | ||
| Affected / at Risk (%) | # Events | |
| Total | 170/453 (37.5%) | |
| Gastrointestinal disorders | ||
| Diarrhea | 5/453 (1.1%) | |
| General disorders | ||
| Application Site Pruritis | 23/453 (5.1%) | |
| Application Site Irritation | 22/453 (4.9%) | |
| Infections and infestations | ||
| Nasopharyngitis | 48/453 (10.6%) | |
| Upper Respiratory Tract Infection | 13/453 (2.9%) | |
| Influenza | 9/453 (2%) | |
| Infectious Mononucleosis | 5/453 (1.1%) | |
| Tonsillitis | 5/453 (1.1%) | |
| Injury, poisoning and procedural complications | ||
| Sunburn | 27/453 (6%) | |
| Ligament Sprain | 6/453 (1.3%) | |
| Nervous system disorders | ||
| Headache | 6/453 (1.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Oropharyngeal Pain | 9/453 (2%) | |
| Skin and subcutaneous tissue disorders | ||
| Acne | 5/453 (1.1%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
All data or results arising out of the study will not be presented or published in any form or media by the PI/Institution without the prior written consent of sponsor.
Results Point of Contact
| Name/Title | Anne Fulton |
|---|---|
| Organization | Galderma S.A. |
| Phone | +1 817-961-5203 |
| anne.fulton@galderma.com |
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT02189629
Other Study ID Numbers:
- RD.06.SPR.18250
First Posted:
Jul 14, 2014
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019