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)

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 Overview

• Status: Recruiting
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Topical aminolevulinate (10% ALA gel); Device: Red light illumination

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Edward V Maytin, M.D. Ph.D.; Phone Number: (216) 445-6676; Email: maytine@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regimen A; Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source	Drug: Topical aminolevulinate (10% ALA gel); 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period; Other Names: Ameluz gel, 10% aminolevulinic acid; Device: Red light illumination; Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2; Other Names: BF-RhodoLED® Light Source
Experimental: Regimen B; Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source	Drug: Topical aminolevulinate (10% ALA gel); 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period; Other Names: Ameluz gel, 10% aminolevulinic acid; Device: Red light illumination; Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2; Other Names: BF-RhodoLED® Light Source
Experimental: Regimen C; Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source	Drug: Topical aminolevulinate (10% ALA gel); 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period; Other Names: Ameluz gel, 10% aminolevulinic acid; Device: Red light illumination; Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2; Other Names: BF-RhodoLED® Light Source

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
Differences in Pain Level Reported Throughout Exposure to Red Light	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.	Pain measured during illumination with red light (during a 10 min period) at Visit 1 and at Visit 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Scores Reported on Patient Satisfaction Survey	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.	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.	At day 2-4 post-treatment

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: The Cleveland Clinic; Biofrontera, Inc.
• Investigators: Principal Investigator: Edward V Maytin, M.D. Ph.D., Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Actinic Keratosis; Photodynamic Therapy; Actinic Keratoses
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: CASE4623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available 12/2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes