Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trifarotene 0.005 % · 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...
Trifarotene 0.005% is a topical cream used for the treatment of acne vulgaris. It is a small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA) for dermatological use. The drug is currently in Phase 3 clinical development and is being studied in patients aged 12 years and older.
Trifarotene 0.005% is a retinoid that targets retinoic acid receptors, specifically the gamma subtype (RAR-gamma), which is involved in skin cell differentiation and inflammation. This mechanism helps treat acne vulgaris by normalizing skin cell turnover and reducing inflammation in affected areas.
Trifarotene 0.005% is being developed by Teva Pharmaceutical Industries Limited, a company traded on the NYSE under the ticker TEVA. The drug is currently in Phase 3 clinical development for the treatment of acne vulgaris.
Trifarotene 0.005% is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The most recent clinical trial for this drug has been completed, and it is being studied for the treatment of acne vulgaris.
Trifarotene 0.005% has one completed Phase 3 clinical trial registered under NCT05550337. This study compared 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 a randomized, double-blind, placebo-controlled study.
Trifarotene 0.005% is being studied as a generic version of AKLIEF, which is also a trifarotene 0.005% cream. The Phase 3 clinical trial NCT05550337 was designed to compare the two products in the treatment of acne vulgaris, indicating they are intended to be therapeutically equivalent.