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

NCT06027619 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: CASE4623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Actinic Keratosis

Keywords

Actinic Keratoses; Actinic Keratosis; Photodynamic Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  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 (3)

• Patient Satisfaction Survey as Measured by Treatment Outcome Score

  6 months

• Patient Satisfaction Survey as Measured by Cosmetic Outcome Score

  At month 6

• Number of Participant Reported Adverse Events and Side Effects

  Up to 6 days (Day 6) after Visit 1

Study Arms (3)

Regimen A

EXPERIMENTAL

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

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

Regimen B

EXPERIMENTAL

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

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

Regimen C

EXPERIMENTAL

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

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

Interventions

Topical aminolevulinate (10% ALA gel) DRUG

10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period

Also known as: Ameluz gel, 10% aminolevulinic acid

Regimen A; Regimen B; Regimen C

Red light illumination DEVICE

Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Also known as: BF-RhodoLED® Light Source

Regimen A; Regimen B; Regimen C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• The Cleveland Clinic: collaborator
• Biofrontera Inc.: collaborator

Study Sites (1)

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

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Johnson JS, Hanna J, Nowacki AS, Anand S, Shen AS, Maytin EV. Painless PDT using 10% aminolevulinate gel and red light: A pilot clinical trial of short-contact protocols to reduce discomfort during illumination. Photodiagnosis Photodyn Ther. 2025 Aug;54:104698. doi: 10.1016/j.pdpdt.2025.104698. Epub 2025 Jun 26.

  PMID: 40581198 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Edward V Maytin
• Organization: Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

maytine@ccf.org

(216) 445-6676

Study Officials

• Edward V Maytin, M.D. Ph.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: October 2, 2023
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available 12/2024

Locations

US (1)