At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp
In Brief
A Phase 2 clinical trial evaluating Broad Area ALA 1-hour incubation, Broad Area ALA 2 hour incubation, and 4 other interventions for Actinic Keratosis. Completed, enrolled 235 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 keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.
Study Details
Timeline
Interventions
20% ALA, broad area, 1 hour incubation
20% ALA broad area 2-hour incubation
20% ALA broad area 3 hour incubation
20% ALA spot 2 hour incubation
Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
10 J/cm2 blue light delivered at 10 mW/cm2