Acne Vulgaris
Conditions
Keywords
Acne vulgaris, Safety, Face, Trunk
Brief summary
Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.
Detailed description
To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.
Interventions
DRUGCD5789 (trifarotene)
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits. * The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face. *
Exclusion criteria
* The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.). * The Subject has more than 1 nodule on the face at Screening and at Baseline visits. * The Subject has any acne cyst on the face at Screening and at Baseline visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) Success Rate up to Week 52 | From Baseline to Week 52 | Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment (PGA) Success Rate up to Week 52 | From Baseline to Week 52 | Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear). |
Countries
Czechia, Germany, Hungary, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD5789 Cream CD5789 Trifarotene 50 microgram/gram | 453 |
| Total | 453 |
Baseline characteristics
| Characteristic | CD5789 Cream |
|---|---|
| Age, Categorical <=18 years | 286 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 167 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 406 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 432 Participants |
| Region of Enrollment Czechia | 104 participants |
| Region of Enrollment Germany | 95 participants |
| Region of Enrollment Hungary | 91 participants |
| Region of Enrollment United States | 163 participants |
| Sex: Female, Male Female | 226 Participants |
| Sex: Female, Male Male | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 453 |
| other Total, other adverse events | 170 / 453 |
| serious Total, serious adverse events | 10 / 453 |
Outcome results
Primary
Investigator Global Assessment (IGA) Success Rate up to Week 52
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CD5789 Cream | Investigator Global Assessment (IGA) Success Rate up to Week 52 | 453 Participants |
Secondary
Physician Global Assessment (PGA) Success Rate up to Week 52
Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CD5789 Cream | Physician Global Assessment (PGA) Success Rate up to Week 52 | 453 Participants |