Symptoms and General Pathology

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Neoplasms

Skin and Connective Tissue Diseases

Pain

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source

Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source

Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source

10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period

Topical aminolevulinate (10% ALA gel)

Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Red light illumination

Edward V Maytin, M.D. Ph.D.

The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are:

* Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance?
* Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance?
* Will the new test regimens achieve reduced pain during illumination?
* Will the new test regimens be safe?

Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)

To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.

To demonstrate that a short-contact PDT protocol with Ameluz and red light generates less pain during illumination than the standard FDA-approved protocol currently used. Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS) at 1 min, 5 min, and 10 min.

To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will be better tolerated and provide higher patient satisfaction than the currently practiced protocol. Participant satisfaction will be measured by completing a Subject Satisfaction Questionnaire survey.

Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.

The Cleveland Clinic

Biofrontera, Inc.

Case Comprehensive Cancer Center

Protoporphyrin IX

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.

Topical Levulan Kerastick is applied to actinic keratoses.

Topical Aminolevulinate

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

Photodynamic therapy (PDT)

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

Edward Maytin, MD, PhD

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.

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.

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

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

All IPD that underlie results in publication

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

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.

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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses	NCT06027619	Actinic Keratos...	Topical aminole... Red light illum...	18 Years -	Case Comprehensive Cancer Center
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses	NCT05923060	Actinic Keratos...	Topical Aminole... Photodynamic th... Red light illum...	18 Years -	Case Comprehensive Cancer Center

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