Trial Outcomes & Findings for CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris (NCT NCT02189629)

NCT ID: NCT02189629

Last Updated: 2019-11-14

Results Overview

Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 453 participants
• Primary outcome timeframe: From Baseline to Week 52
• Results posted on: 2019-11-14

Participant Flow

Participant milestones

Measure	CD5789 Cream CD5789 Trifarotene 50 microgram/gram cream
Overall Study STARTED	453
Overall Study COMPLETED	348
Overall Study NOT COMPLETED	105

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Baseline characteristics by cohort

Measure	CD5789 Cream n=453 Participants CD5789 Trifarotene 50 microgram/gram
Age, Categorical <=18 years	286 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	167 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	226 Participants n=5 Participants
Sex: Female, Male Male	227 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	406 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	432 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Hungary	91 participants n=5 Participants
Region of Enrollment United States	163 participants n=5 Participants
Region of Enrollment Czechia	104 participants n=5 Participants
Region of Enrollment Germany	95 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 52

Population: A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram.

Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).

Outcome measures

Measure	CD5789 Cream n=453 Participants CD5789 Trifarotene 50 microgram/gram
Investigator Global Assessment (IGA) Success Rate up to Week 52	453 Participants

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram

Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).

Outcome measures

Measure	CD5789 Cream n=453 Participants CD5789 Trifarotene 50 microgram/gram
Physician Global Assessment (PGA) Success Rate up to Week 52	453 Participants

Adverse Events

CD5789 Cream

Serious events: 10 serious events

Other events: 170 other events

Deaths: 0 deaths

Serious adverse events

Measure	CD5789 Cream n=453 participants at risk CD5789 Trifarotene 50 microgram/gram
Gastrointestinal disorders Crohn's Disease	0.22% 1/453 • Over 52 Weeks
Gastrointestinal disorders Umbilical Hernia	0.22% 1/453 • Over 52 Weeks
Infections and infestations Appendicitis	0.22% 1/453 • Over 52 Weeks
Infections and infestations Pyelonephritis Acute	0.22% 1/453 • Over 52 Weeks
Nervous system disorders Complex partial seizures	0.22% 1/453 • Over 52 Weeks
Nervous system disorders Complex regional Pain syndrome	0.22% 1/453 • Over 52 Weeks
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.22% 1/453 • Over 52 Weeks
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.22% 1/453 • Over 52 Weeks
Injury, poisoning and procedural complications Post procedural haemorrhage	0.22% 1/453 • Over 52 Weeks
Investigations Liver function test abnormal	0.22% 1/453 • Over 52 Weeks

Other adverse events

Measure	CD5789 Cream n=453 participants at risk CD5789 Trifarotene 50 microgram/gram
Injury, poisoning and procedural complications Sunburn	6.0% 27/453 • Over 52 Weeks
Injury, poisoning and procedural complications Ligament Sprain	1.3% 6/453 • Over 52 Weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	2.0% 9/453 • Over 52 Weeks
Nervous system disorders Headache	1.3% 6/453 • Over 52 Weeks
General disorders Application Site Pruritis	5.1% 23/453 • Over 52 Weeks
General disorders Application Site Irritation	4.9% 22/453 • Over 52 Weeks
Gastrointestinal disorders Diarrhea	1.1% 5/453 • Over 52 Weeks
Skin and subcutaneous tissue disorders Acne	1.1% 5/453 • Over 52 Weeks
Infections and infestations Nasopharyngitis	10.6% 48/453 • Over 52 Weeks
Infections and infestations Upper Respiratory Tract Infection	2.9% 13/453 • Over 52 Weeks
Infections and infestations Influenza	2.0% 9/453 • Over 52 Weeks
Infections and infestations Infectious Mononucleosis	1.1% 5/453 • Over 52 Weeks
Infections and infestations Tonsillitis	1.1% 5/453 • Over 52 Weeks

Additional Information

Anne Fulton

Galderma S.A.

Phone: +1 817-961-5203

Email: anne.fulton@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER