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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborators: Biofrontera, Inc.; The Cleveland Clinic
• Treatments: Aminolevulinic Acid

Criteria

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.