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

NCT05923060 | Completed Phase 2 DMC

• 2 other identifiers: CASE6622R44CA250727
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses; Red Light; Photodynamic Therapy; Protoporphyrin IX

Outcome Measures

Primary Outcomes (3)

• Lesion Clearance

  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

  3 months post PDT treatment.

• Noninvasive optical measurements of photosensitizer (PpIX) in lesions

  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 months post PDT treatment.

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

  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.

  3 months post PDT treatment.

Secondary Outcomes (2)

• Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions

  3 months post PDT treatment.

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

  3 months post PDT treatment.

Study Arms (1)

Standard PDT + topical aminolevulinate + red light illumination

EXPERIMENTAL

Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.

Drug: Topical Aminolevulinate; Procedure: Photodynamic therapy (PDT); Procedure: Red light illumination

Interventions

Topical Aminolevulinate DRUG

Topical Levulan Kerastick is applied to actinic keratoses.

Also known as: Levulan Kerastick, Aminolevulinic Acid, Levulan

Standard PDT + topical aminolevulinate + red light illumination

Photodynamic therapy (PDT) PROCEDURE

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

Standard PDT + topical aminolevulinate + red light illumination

Red light illumination PROCEDURE

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

Standard PDT + topical aminolevulinate + red light illumination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator
• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid; Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Edward Maytin, MD, PhD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: August 25, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Access Criteria: Cleveland Clinic will share de-identified optical digital code from the fluorescence instrument with Physical Sciences, Inc where it will be processed for final spectral analysis

Locations

US (1)