At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Keratoses on the Face
In Brief
A Phase 2 clinical trial evaluating ALA, Topical Solution Vehicle, and 3 other interventions for Actinic Keratosis. Completed, enrolled 137 participants across 8 sites.
Detailed Summary
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
Study Details
Timeline
Interventions
20% ALA applied to face prior to light treatment
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
Microneedling of all visible/palpable AK lesions prior to solution application.
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds