NCT05923060

Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses

Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to test a new video device for actinic keratoses. The device takes images of your skin lesions during the treatment, to learn whether this device can predict how well the treatment is working.

Detailed description

This intervention is designed to help establish what the optimal conditions are for treating actinic keratoses with photodynamic therapy (PDT). The primary outcome of this study is to determine whether the rate of singlet oxygen (sO2) production and/or the initial intralesional photosensitize (PpIX) levels, can predict the clinical responsiveness of AK lesions to PDT. Participants will receive standard red light PDT treatment, except that lesions will be carefully counted beforehand. During the window of red light illumination, photos and a video of one area of skin will be taken to allow us to monitor the progress of the treatment. Any remaining lesions will be counted upon follow-up.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Topical Aminolevulinate	Topical Levulan Kerastick is applied to actinic keratoses.
PROCEDURE	Photodynamic therapy (PDT)	PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells.
PROCEDURE	Red light illumination	To occur post-PTD; used for activation of ALA during photodynamic therapy.

Timeline

• Start date: 2024-08-25
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2023-06-28
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States