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The primary objective is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifarotene Cream | Experimental | Participants will apply Trifarotene 50 mcg/g cream once daily (QD) in the evening for 12 weeks. |
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| Vehicle Cream | Active Comparator | Participants will apply Vehicle cream QD in the evening for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifarotene | Drug | Trifarotene cream applied QD topically. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Investigator Global Assessment (IGA) Success (Face only) at Week 12 | The areas defined for IGA assessment are the forehead, each cheek, chin, and nose. IGA will be confined to a global assessment of each area defined above. IGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Success Rate, defined as the percentage of participants who achieve an IGA score (face only) of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12. | Baseline to Week 12 |
| Change from Baseline to Week 12 in Facial Non-inflammatory Lesion Count | Baseline to Week 12 | |
| Change from Baseline to Week 12 in Facial Inflammatory Lesion Count | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Physician Global Assessment (PGA) Success at Week 12 | The areas defined for PGA assessment are shoulders, upper back and upper anterior chest which are accessible to self-application by the participants. PGA will be confined to a global assessment of each areas defined above. The PGA is a snapshot static assessment to be done prior to detailed lesion counts. PGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. PGA Success, defined as the percentage of participants who achieve a PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 |
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Inclusion Criteria:
Participants must meet the following criteria to be included in the study:
Male or female Chinese participants aged 9 years or older at the screening visit.
A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline.
Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline.
A minimum of 20 inflammatory lesions and 20 non-inflammatory lesions but no more than 100 non-inflammatory lesion counts on the trunk (shoulders, upper back, and upper anterior chest) reachable for self-application of investigational product by the participant at Screening and Baseline (optional criterion for participant between 9 and 11 years of age).
Acne vulgaris severity grade 3 (moderate) on the PGA scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of investigational product by the participant (optional criterion for participants between 9 and 11 years of age).
Female participants of non-childbearing potential, i.e., premenstrual, or postmenopausal. Postmenopausal participants must meet one criterion at Screening:
Female participants of childbearing potential (i.e., fertile, after menarche and until becoming postmenopausal unless permanently sterile) must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test (UPT) at the baseline visit (with a sensitivity of 25 international units per litre [IU/L] or less). They must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product.
Premenstrual participants who start menses during the study must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product.
Willing and able to comply with all the time commitments and procedural requirements of the clinical study protocol.
Understands and signs an informed consent form (ICF) at the screening visit, before any investigational procedures are performed.
Participants who are younger than 18 years of age and whose parent/legal representative is willing/able to comply with the study requirements and understand/sign the ICF at the screening visit, before any investigational procedures are performed, will sign the assent ICF at the screening visit.
At selected clinical sites: If a participant who is 18 years of age or older at the screening visit and agrees to participate in study photographs, verified by dating and signing a separate approved photography ICF. For participants younger than 18 years of age, an assent photography ICF signed by the participant in conjunction with a photography ICF signed by the parents(s)/legal representative at the screening visit.
Participant is informed of terms pertaining to personal information protection and privacy and is willing to share personal information and data, in accordance with local regulations.
Exclusion Criteria:
Participants meeting the following criteria at the screening or baseline visits are ineligible to participate in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galderma Research & Development | Contact | 817-961-5000 | Clinical.Studies@galderma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research & Development Site #5378 | Recruiting | Shanghai | Jing'an District | China |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000629420 | trifarotene |
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| Vehicle Cream | Drug | Vehicle cream applied QD topically. |
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| Baseline to Week 12 |
| Change from Baseline to Week 12 in Truncal Non-inflammatory Lesion Count | Baseline to Week 12 |
| Change from Baseline to Week 12 in Truncal Inflammatory Lesion Count | Baseline to Week 12 |
| Number of Participants With Adverse Events (AEs), Including AEs of Special Interest (AESIs), Treatment-emergent AEs (TEAEs), and Serious AEs (SAEs) | Baseline to Week 12 |
| Investigator's Local Tolerability Assessment | Local tolerability, which includes individual assessment of erythema, scaling, dryness, and stinging/burning, will be graded on a 4-point scale (ranging from 0 [None] to 3 [Severe]) separately for the face and trunk. A higher score indicated a severe outcome. The areas for evaluation on the face include the forehead, nose, chin, and right and left cheeks. The areas for evaluation on the upper trunk include the shoulders, right and left chest, and right and left upper back, which are accessible to self-application by the subject. If IP is applied to the middle and/or lower back, the local tolerability assessment of the trunk will include the upper, middle, and/or lower back, if applicable, and will be analyzed as 1 area. | Baseline, Weeks 1, 2, 4, 8 and 12 |
| Observed Plasma Concentration (Ct) in Selected Participants | Three PK samples will be collected to inform trifarotene exposure in adult participants. | Baseline, Week 4 and Week 12 |