Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Trifarotene 0.005 % Topical Cream
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...
AKLIEF is a small molecule topical cream developed by Teva Pharmaceutical Industries Limited for the treatment of acne vulgaris. It is a prescription therapy that has been evaluated in a Phase 3 clinical trial. AKLIEF is also written as AKLIEF®.
AKLIEF is used for the treatment of acne vulgaris. It is a topical cream applied to the skin. The Phase 3 trial for AKLIEF enrolled participants with acne vulgaris, including individuals aged 12 years and older.
AKLIEF is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is the company responsible for the clinical development of AKLIEF.
AKLIEF has been evaluated in a Phase 3 clinical trial. The trial, NCT05550337, is completed. AKLIEF is an investigational product in clinical development for acne vulgaris.
AKLIEF has been studied in one completed Phase 3 trial, NCT05550337, titled "Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris." The trial enrolled 807 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, AKLIEF and AKLIEF® refer to the same product. The registered trademark symbol is often included in the name. Both names are used interchangeably for the topical acne vulgaris treatment developed by Teva Pharmaceutical Industries Limited.