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

Completed · Phase 2

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID: NCT05923060
Run by: Case Comprehensive Cancer Center
People needed: 14
Starts: 2024-08-25
Expected to finish: 2025-10-31
Last updated by the study team: 2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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