Acne Vulgaris
Conditions
Keywords
Efficacy, Safety, Acne vulgaris
Brief summary
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
Interventions
DRUGCD5789 (trifarotene) 50µg/g Cream
CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
DRUGPlacebo Cream
Placebo cream applied once daily during 12 weeks.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is a male or female, 9 years of age or older, at Screening visit. * The Subject has moderate acne at Screening and Baseline. * The subject is a female of non childbearing potential * The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.
Exclusion criteria
* The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.). * The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial. * The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.) * The subject is unwilling to refrain from use of prohibited medication during the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | 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. |
Countries
Czechia, Hungary, Poland, Romania, Russia, Spain, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD5789 (Trifarotene) 50µg/g Cream CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks. | 602 |
| Placebo Cream Placebo cream applied once daily during 12 weeks. | 610 |
| Total | 1,212 |
Baseline characteristics
| Characteristic | CD5789 (Trifarotene) 50µg/g Cream | Total | Placebo Cream |
|---|---|---|---|
| Age, Categorical <=18 years | 276 Participants | 570 Participants | 294 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 326 Participants | 642 Participants | 316 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 60 Participants | 122 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 542 Participants | 1090 Participants | 548 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Investigator Global Asssessment Almost Clear | 0 participants | 0 participants | 0 participants |
| Investigator Global Asssessment Clear | 0 participants | 0 participants | 0 participants |
| Investigator Global Asssessment Mild | 0 participants | 0 participants | 0 participants |
| Investigator Global Asssessment Moderate | 602 participants | 1212 participants | 610 participants |
| Investigator Global Asssessment Severe | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 69 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) White | 565 Participants | 1119 Participants | 554 Participants |
| Region of Enrollment Czechia | 63 Participants | 123 Participants | 60 Participants |
| Region of Enrollment Hungary | 74 Participants | 140 Participants | 66 Participants |
| Region of Enrollment Poland | 92 Participants | 188 Participants | 96 Participants |
| Region of Enrollment Romania | 64 Participants | 129 Participants | 65 Participants |
| Region of Enrollment Russia | 100 Participants | 181 Participants | 81 Participants |
| Region of Enrollment Spain | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment Ukraine | 71 Participants | 145 Participants | 74 Participants |
| Region of Enrollment United States | 124 Participants | 278 Participants | 154 Participants |
| Sex: Female, Male Female | 357 Participants | 695 Participants | 338 Participants |
| Sex: Female, Male Male | 245 Participants | 517 Participants | 272 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 602 | 0 / 610 |
| other Total, other adverse events | 21 / 602 | 5 / 610 |
| serious Total, serious adverse events | 2 / 602 | 4 / 610 |
Outcome results
Primary
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CD5789 (Trifarotene) 50µg/g Cream | Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | 255 Participants |
| Placebo Cream | Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | 157 Participants |