At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 269 enrolled
Drug / intervention
Aminolevulinic Acid (ALA) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
In Brief
A Phase 3 clinical trial evaluating Aminolevulinic Acid (ALA), Topical Solution Vehicle, and 1 other intervention for Actinic Keratosis. Completed, enrolled 269 participants across 13 sites.
Detailed Summary
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionMar 2015
TodayJul 2026
First PostedMay 14, 2014
Enrollment StartMay 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.1 years ago
Interventions
Aminolevulinic Acid (ALA)drug
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Topical Solution Vehicledrug
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
Blue Light Photodynamic Therapy Illuminator (BLU-U)device
10 J/cm2 blue light delivered at 10mW/cm2