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

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ClinicalTrials.gov Identifier: NCT02566369
Recruitment Status : Completed
First Posted : October 2, 2015
Results First Posted : August 22, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: CD5789 (trifarotene) 50μg/g cream
Drug: Placebo cream
Enrollment 1208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CD5789 (Trifarotene) 50μg/g Cream Placebo Cream
Hide Arm/Group Description CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks. Placebo cream applied once daily for 12 weeks
Period Title: Overall Study
Started 612 596
Completed 540 535
Not Completed 72 61
Arm/Group Title CD5789 (Trifarotene) 50μg/g Cream Placebo Cream Total
Hide Arm/Group Description CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks. Placebo cream applied once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 612 596 1208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 596 participants 1208 participants
<=18 years
314
  51.3%
278
  46.6%
592
  49.0%
Between 18 and 65 years
298
  48.7%
318
  53.4%
616
  51.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 596 participants 1208 participants
Female
305
  49.8%
324
  54.4%
629
  52.1%
Male
307
  50.2%
272
  45.6%
579
  47.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 596 participants 1208 participants
Hispanic or Latino
135
  22.1%
148
  24.8%
283
  23.4%
Not Hispanic or Latino
477
  77.9%
448
  75.2%
925
  76.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 596 participants 1208 participants
American Indian or Alaska Native
11
   1.8%
5
   0.8%
16
   1.3%
Asian
23
   3.8%
32
   5.4%
55
   4.6%
Native Hawaiian or Other Pacific Islander
1
   0.2%
1
   0.2%
2
   0.2%
Black or African American
47
   7.7%
49
   8.2%
96
   7.9%
White
508
  83.0%
484
  81.2%
992
  82.1%
More than one race
8
   1.3%
10
   1.7%
18
   1.5%
Unknown or Not Reported
14
   2.3%
15
   2.5%
29
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 612 participants 596 participants 1208 participants
Canada 70 69 139
Puerto Rico 27 28 55
Hungary 44 44 88
United States 407 395 802
Germany 64 60 124
Physician Global Assessment Scale Face   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 596 participants 1208 participants
Clear
0
   0.0%
0
   0.0%
0
   0.0%
Almost Clear
0
   0.0%
0
   0.0%
0
   0.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
612
 100.0%
596
 100.0%
1208
 100.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description:

0 - Clear (Clear skin with no inflammatory or non-inflammatory lesions.)

  1. - Almost Clear (A few scattered comedones and a few small papules.)
  2. - Mild (Easily recognizable; less than half the surface is involved. Some comedones and some papules and pustules.)
  3. - Moderate (More than half of the surface is involved. Many comedones, papules and pustules. One nodule may be present.)
  4. - Severe (Entire surface is involved. Covered with comedones, numerous papules and pustules. Few nodules may be present.)
1.Primary Outcome
Title Investigator Global Assessment (IGA) Success Rate at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD5789 (Trifarotene) 50μg/g Cream Placebo Cream
Hide Arm/Group Description:
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
Placebo cream applied once daily for 12 weeks
Overall Number of Participants Analyzed 612 596
Measure Type: Count of Participants
Unit of Measure: Participants
180
  29.4%
116
  19.5%
Time Frame Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CD5789 (Trifarotene) 50μg/g Cream Placebo Cream
Hide Arm/Group Description CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks. Placebo cream applied once daily for 12 weeks
All-Cause Mortality
CD5789 (Trifarotene) 50μg/g Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/612 (0.00%)   0/596 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CD5789 (Trifarotene) 50μg/g Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   4/612 (0.65%)   2/596 (0.34%) 
Congenital, familial and genetic disorders     
Hereditary angioedema *  0/612 (0.00%)  1/596 (0.17%) 
Infections and infestations     
Infectious Mononucleosis *  1/612 (0.16%)  0/596 (0.00%) 
Cellulitis *  1/612 (0.16%)  0/596 (0.00%) 
Atypical Pneumonia *  0/612 (0.00%)  1/596 (0.17%) 
Injury, poisoning and procedural complications     
Facial Bones Fracture *  1/612 (0.16%)  0/596 (0.00%) 
Procedural dizziness *  1/612 (0.16%)  0/596 (0.00%) 
Renal and urinary disorders     
Urinary Tract Infection *  0/612 (0.00%)  1/596 (0.17%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CD5789 (Trifarotene) 50μg/g Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   177/612 (28.92%)   74/596 (12.42%) 
General disorders     
Application Site Irritation *  66/612 (10.78%)  4/596 (0.67%) 
Application Site Pruritis *  24/612 (3.92%)  8/596 (1.34%) 
Infections and infestations     
Nasopharyngitis *  24/612 (3.92%)  27/596 (4.53%) 
Upper Respiratory Tract Infection *  10/612 (1.63%)  8/596 (1.34%) 
Influenza *  6/612 (0.98%)  9/596 (1.51%) 
Sinusitis *  6/612 (0.98%)  1/596 (0.17%) 
Injury, poisoning and procedural complications     
Sunburn *  27/612 (4.41%)  5/596 (0.84%) 
Nervous system disorders     
Headache *  6/612 (0.98%)  12/596 (2.01%) 
Skin and subcutaneous tissue disorders     
Skin Irritation *  8/612 (1.31%)  0/596 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne Fulton
Organization: Galderma S.A.
Phone: +1 817-961-5203
EMail: anne.fulton@galderma.com
Layout table for additonal information
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02566369     History of Changes
Other Study ID Numbers: RD.06.SPR.18251
First Submitted: October 1, 2015
First Posted: October 2, 2015
Results First Submitted: April 18, 2019
Results First Posted: August 22, 2019
Last Update Posted: November 11, 2019