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Photodynamic Therapy Monitoring for Actinic Keratosis

Phase 2

Recruiting

Led By Edward Maytin, MD, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Must not have

Female participants cannot be or become pregnant, nor can be nursing while on this study

Patients with history of a photosensitivity disease, such as porphyria cutanea tarda

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post pdt treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new camera device to see if it can predict how well a treatment for skin lesions is working. #medicalresearch

Who is the study for?

This trial is for individuals who can consent to treatment, have at least 10 Actinic Keratoses (AK) lesions on their arms or legs, and two AK lesions close enough to be imaged together. Pregnant or nursing women, those using topical treatments for AK within the last month, with photosensitivity diseases like porphyria cutanea tarda, allergies to study materials, or undergoing other cancer treatments are excluded.

What is being tested?

The study tests a new video device that captures images of skin lesions during photodynamic therapy (PDT) for actinic keratoses. It involves applying a topical drug called Aminolevulinate followed by red light illumination to see if the device can predict treatment success.

What are the potential side effects?

While specific side effects aren't listed here, PDT and Aminolevulinate generally may cause skin reactions such as redness, swelling, burning sensation at the treated area; sensitivity to light; and changes in skin pigmentation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have over 10 skin lesions on my arms or legs, with at least two close together.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not and will not become pregnant or breastfeed during the study.

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I have a history of a condition that makes my skin sensitive to light.

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I am currently receiving treatment for another cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post pdt treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post pdt treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post pdt treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lesion Clearance

Noninvasive optical measurements of photosensitizer (PpIX) in lesions

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

Secondary study objectives

Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard PDT + topical aminolevulinate + red light illuminationExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Photodynamic therapy (PDT)

2020

Completed Phase 2

~80

0 / 4Eligibility criteria met