← Back to Search

Other

Photodynamic Therapy Monitoring for Actinic Keratosis

Phase 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post pdt treatment.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have over 10 skin lesions on my arms or legs, with at least two close together.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lesion Clearance
Noninvasive optical measurements of photosensitizer (PpIX) in lesions
Noninvasive optical measurements of singlet oxygen (sO2) in lesions.
Secondary outcome measures
Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions
Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,351 Total Patients Enrolled
Case Comprehensive Cancer CenterLead Sponsor
453 Previous Clinical Trials
31,849 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,266 Total Patients Enrolled

Media Library

Photodynamic therapy (PDT) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05923060 — Phase 2
Actinic Keratosis Research Study Groups: Standard PDT + topical aminolevulinate + red light illumination
Actinic Keratosis Clinical Trial 2023: Photodynamic therapy (PDT) Highlights & Side Effects. Trial Name: NCT05923060 — Phase 2
Photodynamic therapy (PDT) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05923060 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Standard PDT + topical aminolevulinate + red light illumination procedure a viable option for individuals in terms of safety and efficacy?

"As this is a Phase 2 trial, with some data verifying safety but none demonstrating efficacy, our team at Power judged the security of Standard PDT + topical aminolevulinate + red light illumination to be an intermediate score of two."

Answered by AI

Does this medical trial have vacancies available for participants?

"Affirmative. According to the details listed on clinicaltrials.gov, this medical trial is actively searching for participants; it was first made available on May 22nd 2023 and its most recent update occurred June 20th of that same year. The study requires recruitment of up to 20 individuals from a single site."

Answered by AI

How many subjects are participating in this clinical trial?

"Indeed, clinicaltrials.gov reveals that this experiment is still open for enrollment; it was first posted on May 22nd 2023 and has since been amended on June 20th of the same year. In total, investigators are seeking to recruit up to 20 people from a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
2024. "Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05923060.
All > Photodynamic Therapy > Actinic Keratosis
~13 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top