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

Case Comprehensive Cancer Center30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Actinic Keratosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Minimum of 10 actinic keratoses lesions on the face. * Female subjects must not become pregnant during the study * Subjects 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. * Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material. * Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.

Outcomes

Primary Outcomes

Treatment Efficacy Based on Participant AK Lesion Clearance

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.

Time frame: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)

Differences in Pain Level Reported Throughout Exposure to Red Light

Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain)

Time frame: Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2)

Secondary Outcomes

Patient Satisfaction Survey as Measured by Treatment Outcome Score

Treatment score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.

Time frame: 6 months

Patient Satisfaction Survey as Measured by Cosmetic Outcome Score

Cosmetic score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.

Time frame: At month 6

Number of Participant Reported Adverse Events and Side Effects

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

Time frame: Up to 6 days (Day 6) after Visit 1