Trial Outcomes & Findings for Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris (NCT NCT02566369)
NCT ID: NCT02566369
Last Updated: 2019-11-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1208 participants
Primary outcome timeframe
From Baseline to Week 12
Results posted on
2019-11-12
Participant Flow
Participant milestones
| Measure |
CD5789 (Trifarotene) 50μg/g Cream
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
|
Placebo Cream
Placebo cream applied once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
612
|
596
|
|
Overall Study
COMPLETED
|
540
|
535
|
|
Overall Study
NOT COMPLETED
|
72
|
61
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
CD5789 (Trifarotene) 50μg/g Cream
n=612 Participants
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
|
Placebo Cream
n=596 Participants
Placebo cream applied once daily for 12 weeks
|
Total
n=1208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
314 Participants
n=99 Participants
|
278 Participants
n=107 Participants
|
592 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
298 Participants
n=99 Participants
|
318 Participants
n=107 Participants
|
616 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
305 Participants
n=99 Participants
|
324 Participants
n=107 Participants
|
629 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
307 Participants
n=99 Participants
|
272 Participants
n=107 Participants
|
579 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
135 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
477 Participants
n=99 Participants
|
448 Participants
n=107 Participants
|
925 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
508 Participants
n=99 Participants
|
484 Participants
n=107 Participants
|
992 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
70 participants
n=99 Participants
|
69 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Region of Enrollment
Puerto Rico
|
27 participants
n=99 Participants
|
28 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
44 participants
n=99 Participants
|
44 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
407 participants
n=99 Participants
|
395 participants
n=107 Participants
|
802 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
64 participants
n=99 Participants
|
60 participants
n=107 Participants
|
124 participants
n=206 Participants
|
|
Physician Global Assessment Scale Face
Clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Physician Global Assessment Scale Face
Almost Clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Physician Global Assessment Scale Face
Mild
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Physician Global Assessment Scale Face
Moderate
|
612 Participants
n=99 Participants
|
596 Participants
n=107 Participants
|
1208 Participants
n=206 Participants
|
|
Physician Global Assessment Scale Face
Severe
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Number 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.
Outcome measures
| Measure |
CD5789 (Trifarotene) 50μg/g Cream
n=612 Participants
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
|
Placebo Cream
n=596 Participants
Placebo cream applied once daily for 12 weeks
|
|---|---|---|
|
Investigator Global Assessment (IGA) Success Rate at Week 12
|
180 Participants
|
116 Participants
|
Adverse Events
CD5789 (Trifarotene) 50μg/g Cream
Serious events: 4 serious events
Other events: 177 other events
Deaths: 0 deaths
Placebo Cream
Serious events: 2 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD5789 (Trifarotene) 50μg/g Cream
n=612 participants at risk
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
|
Placebo Cream
n=596 participants at risk
Placebo cream applied once daily for 12 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.16%
1/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.00%
0/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Congenital, familial and genetic disorders
Hereditary angioedema
|
0.00%
0/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.17%
1/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.16%
1/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.00%
0/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.17%
1/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Infections and infestations
Infectious Mononucleosis
|
0.16%
1/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.00%
0/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Infections and infestations
Cellulitis
|
0.16%
1/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.00%
0/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.17%
1/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
Other adverse events
| Measure |
CD5789 (Trifarotene) 50μg/g Cream
n=612 participants at risk
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
|
Placebo Cream
n=596 participants at risk
Placebo cream applied once daily for 12 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Sunburn
|
4.4%
27/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.84%
5/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Nervous system disorders
Headache
|
0.98%
6/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
2.0%
12/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
General disorders
Application Site Irritation
|
10.8%
66/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.67%
4/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
General disorders
Application Site Pruritis
|
3.9%
24/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
1.3%
8/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
1.3%
8/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.00%
0/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
24/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
4.5%
27/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.6%
10/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
1.3%
8/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Infections and infestations
Influenza
|
0.98%
6/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
1.5%
9/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
|
Infections and infestations
Sinusitis
|
0.98%
6/612 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
0.17%
1/596 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60