Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AKLIEF®
AKLIEF · 1 trial · 1 indication
Mean percent change from screening/baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Mean percent change from screening/baseline to week 12 in the noninflammatory (open and closed comedones) lesion counts.
| Arm | Type | Description |
|---|---|---|
| Test: Trifarotene Cream, 0.005% | EXPERIMENTAL | Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days. |
| AKLIEF® | ACTIVE_COMPARATOR | AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days. |
| Vehicle Product | PLACEBO_COMPARATOR | Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days. |
| Name | Type | Description |
|---|---|---|
| Trifarotene 0.005 % Topical Cream | DRUG | Cream |
| AKLIEF® | DRUG | Cream |
| Placebo | DRUG | Cream |
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. 2. Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB/IEC approved written informed consent. Subjects 12 to 17 years of age incl...