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

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.

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.

Inclusion Criteria:

• Participants of at least 18 years of age, with at least 10 AK lesions on the arms or legs, and with two AK lesions close enough to be seen together within a selected region of interest.
• Female participants must not become pregnant during the study. The effects of 5-aminolevulinic acid (LevulanTM) on the human fetus are unknown. For this reason, participants of child-bearing potential must agree to use contraception. However, we note here that the vast majority of participants with chronic sun-induced AK lesions are beyond the age of menopause.
• Participants must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Pregnant or nursing.
• 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.
• Participants with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
• Participants with history of a photosensitivity disease, such as porphyria cutanea tarda.