Trial Outcomes & Findings for Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris (NCT NCT02556788)

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

1212 participants

Primary outcome timeframe

From Baseline to Week 12

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	CD5789 (Trifarotene) 50µg/g Cream CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo Cream Placebo cream applied once daily during 12 weeks.
Overall Study STARTED	602	610
Overall Study COMPLETED	558	573
Overall Study NOT COMPLETED	44	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CD5789 (Trifarotene) 50µg/g Cream n=602 Participants CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo Cream n=610 Participants Placebo cream applied once daily during 12 weeks.	Total n=1212 Participants Total of all reporting groups
Age, Categorical <=18 years	276 Participants n=99 Participants	294 Participants n=107 Participants	570 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	326 Participants n=99 Participants	316 Participants n=107 Participants	642 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	357 Participants n=99 Participants	338 Participants n=107 Participants	695 Participants n=206 Participants
Sex: Female, Male Male	245 Participants n=99 Participants	272 Participants n=107 Participants	517 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	60 Participants n=99 Participants	62 Participants n=107 Participants	122 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	542 Participants n=99 Participants	548 Participants n=107 Participants	1090 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	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	27 Participants n=99 Participants	42 Participants n=107 Participants	69 Participants n=206 Participants
Race (NIH/OMB) White	565 Participants n=99 Participants	554 Participants n=107 Participants	1119 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants	3 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment Romania	64 Participants n=99 Participants	65 Participants n=107 Participants	129 Participants n=206 Participants
Region of Enrollment Hungary	74 Participants n=99 Participants	66 Participants n=107 Participants	140 Participants n=206 Participants
Region of Enrollment United States	124 Participants n=99 Participants	154 Participants n=107 Participants	278 Participants n=206 Participants
Region of Enrollment Czechia	63 Participants n=99 Participants	60 Participants n=107 Participants	123 Participants n=206 Participants
Region of Enrollment Ukraine	71 Participants n=99 Participants	74 Participants n=107 Participants	145 Participants n=206 Participants
Region of Enrollment Poland	92 Participants n=99 Participants	96 Participants n=107 Participants	188 Participants n=206 Participants
Region of Enrollment Russia	100 Participants n=99 Participants	81 Participants n=107 Participants	181 Participants n=206 Participants
Region of Enrollment Spain	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Investigator Global Asssessment Clear	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Investigator Global Asssessment Almost Clear	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Investigator Global Asssessment Mild	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Investigator Global Asssessment Moderate	602 participants n=99 Participants	610 participants n=107 Participants	1212 participants n=206 Participants
Investigator Global Asssessment Severe	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 12

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.

Outcome measures

Outcome measures
Measure	CD5789 (Trifarotene) 50µg/g Cream n=598 Participants CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo Cream n=609 Participants Placebo cream applied once daily during 12 weeks.
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)	255 Participants	157 Participants

Adverse Events

CD5789 (Trifarotene) 50µg/g Cream

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo Cream

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CD5789 (Trifarotene) 50µg/g Cream n=602 participants at risk CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo Cream n=610 participants at risk Placebo cream applied once daily during 12 weeks.
Injury, poisoning and procedural complications Ligament Sprain	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.16% 1/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Psychiatric disorders Suicide Attempt	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.16% 1/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Psychiatric disorders Major Depression	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Infections and infestations Appendicitis	0.00% 0/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.16% 1/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Infections and infestations Sinusitis	0.00% 0/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.16% 1/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).

Other adverse events

Additional Information

Anne Fulton

Galderma S.A.

Phone: +1 817-961-5203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	CD5789 (Trifarotene) 50µg/g Cream n=602 participants at risk CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.	Placebo Cream n=610 participants at risk Placebo cream applied once daily during 12 weeks.
Injury, poisoning and procedural complications Sunburn	0.33% 2/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Injury, poisoning and procedural complications Drug Administered at Inappropriate Site	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Investigations Blood Bilirubin Increased	0.00% 0/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.16% 1/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Investigations Blood Creatinine Increased	0.00% 0/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.16% 1/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Blood and lymphatic system disorders Lymphadenopathy	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Eye disorders Eyelid Exfoliation	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Eye disorders Eyelid Edema	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
General disorders Application Site Irritation	2.5% 15/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
General disorders Application Site Puritis	0.83% 5/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.33% 2/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
General disorders Application Site Pain	0.66% 4/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
General disorders Application Site Dryness	0.50% 3/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
General disorders Application Site Erosion	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
General disorders Application Site Erythema	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Psychiatric disorders Insomnia	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Gastrointestinal disorders Cheilitis	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • 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	0.33% 2/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • 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 Fissures	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Infections and infestations Herpes Simplex	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Infections and infestations Tinea Versicolor	0.17% 1/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.00% 0/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Infections and infestations Oral Herpes	0.00% 0/602 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).	0.16% 1/610 • Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).