Short Contact Photodynamic Therapy for Actinic Keratosis

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Topical treatments, Cancer therapies

Disqualifiers: Pregnancy, Photosensitivity, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with at least 10 actinic keratoses lesions on their face, who are not pregnant or nursing, and have stopped any topical AK treatments for a month. It excludes those undergoing cancer treatment, allergic to the study materials, or with photosensitivity diseases.

Inclusion Criteria

I have at least 10 rough, scaly patches on my face.

I will not become pregnant during the study.

Subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

I stopped using topical treatments on my AKs at least a month ago.

I am not receiving treatment for another cancer.

Pregnant or nursing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Photodynamic Therapy (PDT) with 10% ALA gel and red light exposure. Incubation periods vary between 10, 20, and 60 minutes.

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lesion clearance and patient satisfaction.

6 months

2 visits (in-person)

Treatment Details

Interventions

• Red light illumination
• Topical aminolevulinate (10% ALA gel)

Trial Overview The trial tests if shorter contact times using a nanoemulsion (10% ALA gel) before red light exposure in PDT can effectively treat actinic keratosis with less pain. Participants will be randomly assigned to one of three groups based on different incubation times: 10, 20, or 60 minutes.

Participant Groups

Group I: Regimen C Experimental Treatment 2 Interventions

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

Group II: Regimen B Experimental Treatment 2 Interventions

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

Group III: Regimen A Experimental Treatment 2 Interventions

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

Red light illumination is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Red Light Therapy for:

• Skin conditions (e.g., wrinkles, psoriasis, acne)
• Hair loss
• Pain relief
• Wound healing

Approved in European Union as Photobiomodulation for:

• Skin conditions (e.g., wrinkles, psoriasis, acne)
• Hair loss
• Pain relief
• Wound healing

Approved in Canada as Low-Level Laser Therapy (LLLT) for:

• Skin conditions (e.g., wrinkles, psoriasis, acne)
• Hair loss
• Pain relief
• Wound healing

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Biofrontera, Inc.

Collaborator

Trials

2

Recruited

50+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+