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

NCT06027619 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-23

Study results available
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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

Interventions

DRUG

Topical aminolevulinate (10% ALA gel)

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

DEVICE

Red light illumination

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

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Biofrontera Inc.

    collaborator INDUSTRY

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Edward V Maytin, M.D. Ph.D. · Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2024-07-08
Completion
2024-07-08
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027619 on ClinicalTrials.gov