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Device

Short Contact Photodynamic Therapy for Actinic Keratosis

Phase 2
Waitlist Available
Led By Edward V Maytin, M.D. Ph.D.
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum of 10 actinic keratoses lesions on the face.
Female subjects must not become pregnant during the study
Must not have
Currently undergoing treatment for other cancers with medical or radiation therapy.
Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up lesion clearance at visit 3 (month 2) and at visit 4 (month 6)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if shorter PDT treatments can still effectively treat AK and reduce patients' pain during treatment.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort or pain during illumination and skin reactions related to the application of the ALA gel and subsequent light exposure. The severity of these side effects could vary depending on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least 10 rough, scaly patches on my face.
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I will not become pregnant during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not receiving treatment for another cancer.
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I have a history of a condition that makes my skin sensitive to light.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~lesion clearance at visit 3 (month 2) and at visit 4 (month 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and lesion clearance at visit 3 (month 2) and at visit 4 (month 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences in Pain Level Reported Throughout Exposure to Red Light
Treatment Efficacy based on Participant AK Lesion Clearance
Secondary study objectives
Differences in Scores Reported on Patient Satisfaction Survey
Number of Participant Reported Adverse Events and side effects

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Regimen CExperimental Treatment2 Interventions
Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source
Group II: Regimen BExperimental Treatment2 Interventions
Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source
Group III: Regimen AExperimental Treatment2 Interventions
Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source

Find a Location

Who is running the clinical trial?

Biofrontera, Inc.UNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
33,406 Total Patients Enrolled
The Cleveland ClinicOTHER
1,053 Previous Clinical Trials
1,371,144 Total Patients Enrolled
~14 spots leftby Nov 2025
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