At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light
In Brief
A Phase 2 clinical trial evaluating Aminolevulinic Acid, Topical Solution Vehicle, and 2 other interventions for Actinic Keratosis. Completed, enrolled 166 participants across 8 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 (AK) on the face, following treatment with liquid nitrogen cryotherapy.
Study Details
Timeline
Interventions
20% ALA applied to face for one hour prior to 10 J/cm2 blue light
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
10 J/cm2 blue light delivered at 10 mW/cm2
Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.