At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 487 enrolled
Drug / intervention
A-101 Solution +1 moredrug
Likely dose
A-101 Solution 40%AI-extracted
Key inclusion· 6
- ✓Age at least 18 years
- ✓Clinical diagnosis of stable, clinically typical seborrheic keratosis
- ✓At least 4 appropriate target lesions on trunk, extremities, or face with clinically typical appearance, PLA ≥2, discrete, not covered with interfering hair, not in intertriginous folds, not on eyelids, not within 5mm of orbital rim, and not pedunculated
- ✓Women of childbearing potential must have negative urine pregnancy test and use active birth control
Key exclusion· 10
- ✕Clinically atypical or rapidly growing seborrheic keratosis lesions
- ✕Multiple eruptive seborrheic keratosis lesions (Sign of Lesser-Trelat)
- ✕Current systemic malignancy
- ✕Systemic retinoids within 180 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Vehicle-Controlled, PArallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
In Brief
A Phase 3 clinical trial evaluating A-101 Solution and Vehicle Solution for Seborrheic Keratosis. Completed, enrolled 487 participants across 1 site.
Detailed Summary
This is a randomized, double-blind, vehicle-controlled, parallel group study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeborrheic Keratosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedJan 2016
Primary CompletionOct 2016
TodayJul 2026
First PostedJan 28, 2016
Enrollment StartJan 1, 2016
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago
Interventions
A-101 Solutiondrug
Vehicle Solutionother
Placebo