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Completed

NCT Number: NCT05923060

Imaging Techniques to Monitor Photosensitizer and sO2 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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical Aminolevulinate

Drug

Topical Levulan Kerastick is applied to actinic keratoses.

Other names: Levulan Kerastick, Aminolevulinic Acid, Levulan

Photodynamic Therapy (PDT)

Procedure

PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells.

Red light illumination

Procedure

To occur post-PTD; used for activation of ALA during photodynamic therapy.

Primary outcomes

  1. Lesion Clearance

    Time frame: 3 months post PDT treatment.

    Based on the rate of sO2 production, and/or the initial level of PpIX, is significantly correlated with the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the decrease in the number of lesions

  2. Noninvasive optical measurements of photosensitizer (PpIX) in lesions

    Time frame: 3 months post PDT treatment.

    To determine whether the initial level of PpIX can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in PpIX value before and after red light illumination.

  3. Noninvasive optical measurements of singlet oxygen (sO2) in lesions.

    Time frame: 3 months post PDT treatment.

    To determine whether the rate of sO2 production can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in sO2 value before and after red light illumination.

Secondary outcomes

  1. Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions

    Time frame: 3 months post PDT treatment.

    To characterize the variability in PpIX production between similarly-sized lesions. This will be measured by the accumulation of PpIX.

  2. Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions

    Time frame: 3 months post PDT treatment.

    To characterize the variability in sO2 generation between similarly-sized lesions, and to test whether production of sO2 during PDT correlates with the amount of photosensitizer available in AK lesions. This will be measured by sO2 production, measured in real-time by sO2 dosimeter.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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