Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02667236 | A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis. | PHASE3 | COMPLETED | 450 | — | — | Jan 1, 2016 | Oct 1, 2016 | Feb 6, 2018 | 1 | United States |
| NCT02667275 | A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis | PHASE3 | COMPLETED | 487 | — | — | Jan 1, 2016 | Oct 1, 2016 | Feb 6, 2018 | 1 | United States |
| NCT02667288 | An Open-Label Safety Study of A-101 Solution | PHASE3 | COMPLETED | 147 | — | — | Jan 1, 2016 | Oct 1, 2016 | Feb 7, 2018 | 1 | United States |
| NCT03148691 | A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis | PHASE2 | COMPLETED | 253 | — | — | May 17, 2017 | Apr 3, 2018 | May 6, 2019 | 9 | United States |
| NCT02260180 | Study of A-101 for the Treatment of Seborrheic Keratosis | PHASE2 | COMPLETED | 119 | — | — | Oct 1, 2014 | Mar 1, 2015 | Dec 2, 2020 | 4 | United States |
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.
Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion 1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) 2. Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm) 3. Thick: a visible seborrheic keratosis lesion (thickness \> 1 mm)
The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.
| Arm | Type | Description |
|---|---|---|
| A-101 Solution | ACTIVE_COMPARATOR | A-101 Solution 40% administered once |
| Vehicle Solution | PLACEBO_COMPARATOR | Vehicle Solution administered once |
| Vehicle | PLACEBO_COMPARATOR | Vehicle Topical Solution |
| A-101 Low Dose | ACTIVE_COMPARATOR | A-101 Low Dose Topical Solution |
| A-101 High Dose | ACTIVE_COMPARATOR | A-101 High DoseTopical Solution |
| A-101 40% | ACTIVE_COMPARATOR | A-101 40% Topical Solution |
| A-101 32.5% | ACTIVE_COMPARATOR | A-101 32.5% Topical Solution |
| A-101 Vehicle Topical Solution | PLACEBO_COMPARATOR | A-101 0% Topical Solution (vehicle) |
| Name | Type | Description |
|---|---|---|
| A-101 Solution | DRUG | Active Drug |
| Vehicle Solution | OTHER | Placebo |
| A-101 | DRUG | Topical Solution |
Inclusion Criteria: 1. Subject is at least 18 years of age 2. Clinical diagnosis of stable clinically typical seborrheic keratosis 3. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below: * Have a ...