NCT02124733

Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.

Detailed description

This study is being done to compare a modified version of the standard ALA-PDT (Aminolevulinate-Photodynamic Therapy) treatment of actinic keratoses, to a modified version in which light exposure begins immediately after application of the Levulan. We hypothesize that this will yield a therapeutic efficacy equivalent to the standard ALA-PDT regimen, but will cause less pain during the light exposure. The study employs a bilateral design in which the left versus right sides of the treatment area are compared in the exact same patient. There are 3 arms of the study, each having a different time duration of light exposure in the modified regimen to determine which one is most efficacious

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
PROCEDURE	Aminolevulinic acid based photodynamic therapy	The PDT treatments will be done in two stages. ALA (Levulan® Kerastick™) will be applied to the entire treatment area, and then the longer light exposure (lasting up to 1 hr) will be performed on one-half of the treatment area (Side A). After that, a shorter (16 min 40 sec) light exposure will be done on the other half (Side B).

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-10-01
• Completion: 2018-12-01
• First posted: 2014-04-28
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States