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Trial record 72 of 163 for:    acne AND Vehicle

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

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ClinicalTrials.gov Identifier: NCT02556788
Recruitment Status : Completed
First Posted : September 22, 2015
Results First Posted : September 2, 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 1212
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 during 12 weeks. Placebo cream applied once daily during 12 weeks.
Period Title: Overall Study
Started 602 610
Completed 558 573
Not Completed 44 37
Arm/Group Title CD5789 (Trifarotene) 50µg/g Cream Placebo Cream Total
Hide Arm/Group Description CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks. Placebo cream applied once daily during 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 602 610 1212
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 602 participants 610 participants 1212 participants
<=18 years
276
  45.8%
294
  48.2%
570
  47.0%
Between 18 and 65 years
326
  54.2%
316
  51.8%
642
  53.0%
>=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 602 participants 610 participants 1212 participants
Female
357
  59.3%
338
  55.4%
695
  57.3%
Male
245
  40.7%
272
  44.6%
517
  42.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 602 participants 610 participants 1212 participants
Hispanic or Latino
60
  10.0%
62
  10.2%
122
  10.1%
Not Hispanic or Latino
542
  90.0%
548
  89.8%
1090
  89.9%
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 602 participants 610 participants 1212 participants
American Indian or Alaska Native
1
   0.2%
2
   0.3%
3
   0.2%
Asian
2
   0.3%
6
   1.0%
8
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.2%
1
   0.1%
Black or African American
27
   4.5%
42
   6.9%
69
   5.7%
White
565
  93.9%
554
  90.8%
1119
  92.3%
More than one race
2
   0.3%
2
   0.3%
4
   0.3%
Unknown or Not Reported
5
   0.8%
3
   0.5%
8
   0.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 602 participants 610 participants 1212 participants
Romania
64
  10.6%
65
  10.7%
129
  10.6%
Hungary
74
  12.3%
66
  10.8%
140
  11.6%
United States
124
  20.6%
154
  25.2%
278
  22.9%
Czechia
63
  10.5%
60
   9.8%
123
  10.1%
Ukraine
71
  11.8%
74
  12.1%
145
  12.0%
Poland
92
  15.3%
96
  15.7%
188
  15.5%
Russia
100
  16.6%
81
  13.3%
181
  14.9%
Spain
14
   2.3%
14
   2.3%
28
   2.3%
Investigator Global Asssessment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 602 participants 610 participants 1212 participants
Clear 0 0 0
Almost Clear 0 0 0
Mild 0 0 0
Moderate 602 610 1212
Severe 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) Score of 1 (Almost Clear) or 0 (Clear)
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 during 12 weeks.
Placebo cream applied once daily during 12 weeks.
Overall Number of Participants Analyzed 598 609
Measure Type: Count of Participants
Unit of Measure: Participants
255
  42.6%
157
  25.8%
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 during 12 weeks. Placebo cream applied once daily during 12 weeks.
All-Cause Mortality
CD5789 (Trifarotene) 50µg/g Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/602 (0.00%)   0/610 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CD5789 (Trifarotene) 50µg/g Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   2/602 (0.33%)   4/610 (0.66%) 
Infections and infestations     
Appendicitis *  0/602 (0.00%)  1/610 (0.16%) 
Sinusitis *  0/602 (0.00%)  1/610 (0.16%) 
Injury, poisoning and procedural complications     
Ligament Sprain *  1/602 (0.17%)  0/610 (0.00%) 
Psychiatric disorders     
Suicide Attempt *  1/602 (0.17%)  1/610 (0.16%) 
Major Depression *  1/602 (0.17%)  0/610 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma *  0/602 (0.00%)  1/610 (0.16%) 
*
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   21/602 (3.49%)   5/610 (0.82%) 
Blood and lymphatic system disorders     
Lymphadenopathy *  1/602 (0.17%)  0/610 (0.00%) 
Eye disorders     
Eyelid Exfoliation *  1/602 (0.17%)  0/610 (0.00%) 
Eyelid Edema *  1/602 (0.17%)  0/610 (0.00%) 
Gastrointestinal disorders     
Cheilitis *  1/602 (0.17%)  0/610 (0.00%) 
General disorders     
Application Site Irritation *  15/602 (2.49%)  0/610 (0.00%) 
Application Site Puritis *  5/602 (0.83%)  2/610 (0.33%) 
Application Site Pain *  4/602 (0.66%)  0/610 (0.00%) 
Application Site Dryness *  3/602 (0.50%)  0/610 (0.00%) 
Application Site Erosion *  1/602 (0.17%)  0/610 (0.00%) 
Application Site Erythema *  1/602 (0.17%)  0/610 (0.00%) 
Infections and infestations     
Herpes Simplex *  1/602 (0.17%)  0/610 (0.00%) 
Tinea Versicolor *  1/602 (0.17%)  0/610 (0.00%) 
Oral Herpes *  0/602 (0.00%)  1/610 (0.16%) 
Injury, poisoning and procedural complications     
Sunburn *  2/602 (0.33%)  0/610 (0.00%) 
Drug Administered at Inappropriate Site *  1/602 (0.17%)  0/610 (0.00%) 
Investigations     
Blood Bilirubin Increased *  0/602 (0.00%)  1/610 (0.16%) 
Blood Creatinine Increased *  0/602 (0.00%)  1/610 (0.16%) 
Psychiatric disorders     
Insomnia *  1/602 (0.17%)  0/610 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin Irritation *  2/602 (0.33%)  0/610 (0.00%) 
Skin Fissures *  1/602 (0.17%)  0/610 (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: NCT02556788     History of Changes
Other Study ID Numbers: RD.06.SPR.18252
First Submitted: September 18, 2015
First Posted: September 22, 2015
Results First Submitted: April 18, 2019
Results First Posted: September 2, 2019
Last Update Posted: November 11, 2019