Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A-101 25% · 1 trial · 1 indication
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
| Arm | Type | Description |
|---|---|---|
| A-101 25% | ACTIVE_COMPARATOR | Low dose group |
| A-101 32.5% | ACTIVE_COMPARATOR | Mid Dose Group |
| A-101 40% | ACTIVE_COMPARATOR | High Dose Group |
| A-101 Vehicle | PLACEBO_COMPARATOR | Placebo group |
| Name | Type | Description |
|---|---|---|
| A-101 25% | DRUG | Low Dose Concentration of A-101 applied to one of 4 Target Lesions |
| A-101 32.5% | DRUG | Mid Dose Concentration of A-101 applied to one of 4 Target Lesions |
| A-101 40% | DRUG | High Dose Concentration A-101 applied to one of 4 Target Lesions |
| A-101 Vehicle | DRUG | Placebo applied to one of 4 Target Lesions |
Inclusion Criteria: 1. Is at least 18 years of age 2. Has a clinical diagnosis of stable clinically typical seborrheic keratosis 3. Has at least 4 appropriate seborrheic keratosis target lesions on the back 4. If subject is a women of childbearing potential, she must have a negative urine pregnancy...
A-101 25% is an investigational small molecule being developed for the treatment of seborrheic keratosis (SK), a common non-cancerous skin growth. It is applied topically to treat the condition. The drug is currently in clinical development and has not been approved by the FDA.
A-101 25% is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ACRS. The company is conducting clinical trials to evaluate the safety and effectiveness of this investigational drug for seborrheic keratosis.
A-101 25% is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the safety, tolerability, and effectiveness of the drug in subjects with seborrheic keratosis. The drug remains investigational and is not yet approved for commercial use.
A-101 25% has been studied in one completed Phase 1 clinical trial, identified as NCT01986920. This randomized, double-blind, placebo-controlled study enrolled 35 participants with seborrheic keratosis in the United States. The trial assessed the safety, tolerability, and effectiveness of the drug.
No, A-101 25% is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for seborrheic keratosis. The completed Phase 1 trial evaluated its safety and effectiveness, but further clinical studies and regulatory review are required before any potential approval.