At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 450 enrolled
Drug / intervention
A-101 Solution +1 moredrug
Likely dose
A-101 Solution 40%AI-extracted
Key inclusion· 4
- ✓Age ≥18 years
- ✓Clinical diagnosis of stable, clinically typical seborrheic keratosis
- ✓4 eligible seborrheic keratosis target lesions on trunk, extremities, or face with clinically typical appearance, PLA ≥2, discrete, non-pedunculated, not on eyelids, not within 5mm of orbital rim, and not in intertriginous folds
- ✓Good general health with no known disease state or physical condition that would impair evaluation or expose subject to unacceptable risk
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 450 participants across 1 site.
Detailed Summary
This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.
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
Active Drug
Vehicle Solutionother
Placebo