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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Topical aminolevulinate (10% ALA gel); Device: Red light illumination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06027619

CASE4623

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Regimen A

Experimental group

Description:

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

Treatment:

Device: Red light illumination

Drug: Topical aminolevulinate (10% ALA gel)

Regimen B

Experimental group

Description:

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

Treatment:

Device: Red light illumination

Drug: Topical aminolevulinate (10% ALA gel)

Regimen C

Experimental group

Description:

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

Treatment:

Device: Red light illumination

Drug: Topical aminolevulinate (10% ALA gel)