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Also known as A-101 Solution 40, A-101 Topical Solution 40%
A-101 40% · 2 trials · 2 indications
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
The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.
| 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 |
| A-101 Solution 40 | EXPERIMENTAL | A-101 Solution 40% administered once per week |
| A-101 Solution 45 | EXPERIMENTAL | A-101 Solution 45% administered once per week |
| Vehicle Solution | PLACEBO_COMPARATOR | Vehicle Solution administered once per week |
| Name | Type | Description |
|---|---|---|
| A-101 Topical Solution 40% | DRUG | A-101 Topical Solution 40% |
| A-101 Solution 40 | DRUG | - |
| A-101 Solution 45 | DRUG | - |
| Vehicle Solution | DRUG | - |
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 developed by Aclaris Therapeutics, Inc. (ticker ACRS) for dermatological conditions. It has been studied in Phase 2 clinical trials for the treatment of common warts and dermatosis papulosa nigra, a benign skin condition characterized by small dark bumps.
A-101 40% has been evaluated for two dermatological indications: common warts and dermatosis papulosa nigra. Both are skin conditions treated in outpatient dermatology settings. The clinical program studied the topical solution in adults aged 18 years and older, with no biomarker-based patient selection.
A-101 40% is developed by Aclaris Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol ACRS. Aclaris is the sponsor of the clinical trials evaluating the topical solution in dermatological indications including common warts and dermatosis papulosa nigra.
A-101 40% is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 2 program includes completed trials in common warts and dermatosis papulosa nigra, with no active trials currently listed.
A-101 40% has been studied in two completed Phase 2 trials. NCT02669862 evaluated A-101 Solution in 98 subjects with common warts in the United States. NCT03224598 evaluated A-101 Topical Solution in 39 subjects with dermatosis papulosa nigra, also in the United States. Both were randomized, double-blind, and placebo-controlled.
Yes. A-101 40%, A-101 Solution 40, A-101 40, and A-101 Topical Solution 40% are alternative names for the same investigational product developed by Aclaris Therapeutics. The different names reflect variations in how the topical solution has been referenced across clinical trial documentation and company communications.