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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Participants who have at least 10 Actinic Keratoses lesions on the arms of legs, and with two AK lesions close enough to be seen together within a selected region of interest (ROI)
  • Participants must be able to understand and are willing to sign a written informed consent document

Exclusion Criteria:

  • Female participants cannot be or become pregnant, nor can be nursing while on this study
  • Using any topical treatment on their AKs; must stop at least one month prior
  • Currently undergoing treatment for other cancers with medical or radiation therapy
  • Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
  • Patients with history of a photosensitivity disease, such as porphyria cutanea tarda

Study details
    Actinic Keratoses

NCT05923060

Case Comprehensive Cancer Center

16 October 2025

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