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Completed

NCT Number: NCT06027619

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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical aminolevulinate (10% ALA gel)

Drug

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

Other names: Ameluz gel, 10% aminolevulinic acid

Red light illumination

Device

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

Primary outcomes

  1. Treatment Efficacy Based on Participant AK Lesion Clearance

    Time frame: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)

    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.

  2. Differences in Pain Level Reported Throughout Exposure to Red Light

    Time frame: Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2)

    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)

Secondary outcomes

  1. Patient Satisfaction Survey as Measured by Treatment Outcome Score

    Time frame: 6 months

    Treatment score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.

  2. Patient Satisfaction Survey as Measured by Cosmetic Outcome Score

    Time frame: At month 6

    Cosmetic score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.

  3. Number of Participant Reported Adverse Events and Side Effects

    Time frame: Up to 6 days (Day 6) after Visit 1

    Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • Biofrontera Inc.
  • The Cleveland Clinic

Registry information

Official study title

Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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