Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A-101 40% · 1 trial · 1 indication
Efficacy endpoints will include summary statistics (frequency distributions, proportions, means, medians and standard deviations, as appropriate) by visit for the following parameters: Physician's DPN Lesion Assessment scale results per treated lesion, subject responders defined by Physician's DPN Lesion Assessment scale outcome, and changes from baseline treated lesion diameter Physician's DPN Lesion Assessment Grade Descriptor 0 Clear: no visible DPN lesion; 1. Near Clear: a slightly visible DPN lesion; lesion may be macular 2. Small: a visible DPN lesion with a diameter of less than 3 mm 3. Large : a visible DPN lesion that is elevated with a diameter of ≥3 mm
| Arm | Type | Description |
|---|---|---|
| No medical abrading | EXPERIMENTAL | A-101 40% without medically abrading the identified DPN prior to treatment |
| Medically abrading | EXPERIMENTAL | A-101 40% with the identified DPN lesions medically abraded prior to treatment |
| Initial cohort - no medical abrading | EXPERIMENTAL | A-101 40% without medically abrading the identified DPN prior to treatment |
| Name | Type | Description |
|---|---|---|
| A-101 Topical Solution 40% | DRUG | A-101 Topical Solution 40% |
Inclusion Criteria: 1. Provisions of written informed consent for participation in this study. 2. Male or female ≥ 18 years old. 3. Subject has a clinical diagnosis of dermatosis papulose nigra. 4. Fitzpatrick Skin Type of 5 or 6 5. Subject has 4 target DPN lesions located in an area that has not b...
A-101 40 is an investigational small molecule topical solution being developed for dermatological conditions, specifically common warts and dermatosis papulosa nigra (DPN). It is not FDA approved and remains in clinical development.
A-101 40 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ACRS.
A-101 40 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one for common warts and one for dermatosis papulosa nigra, but the drug remains investigational and is not yet approved.
A-101 40 has completed two Phase 2 trials: NCT02669862 in common warts with 98 participants, and NCT03224598 in dermatosis papulosa nigra with 39 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States.
A-101 40 is a small molecule topical solution. Its specific molecular target has not been disclosed in the available clinical trial information.