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Device

Short Contact Photodynamic Therapy for Actinic Keratosis

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up lesion clearance at visit 3 (month 2) and at visit 4 (month 6)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ lesion clearance at visit 3 (month 2) and at visit 4 (month 6)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Differences in Pain Level Reported Throughout Exposure to Red Light

Treatment Efficacy based on Participant AK Lesion Clearance

Secondary outcome measures

Differences in Scores Reported on Patient Satisfaction Survey

Number of Participant Reported Adverse Events and side effects

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Biofrontera, Inc.UNKNOWN

Case Comprehensive Cancer CenterLead Sponsor

453 Previous Clinical Trials

31,860 Total Patients Enrolled

The Cleveland ClinicOTHER

1,030 Previous Clinical Trials

1,365,528 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree of peril would individuals be exposed to if they used Regimen A?

"Although the efficacy of Regimen A has yet to be confirmed, there is sufficient evidence that it can be safely administered. Our team at Power gave Regimen A a safety rating of 2 on our scale from 1-3."

Answered by AI

Is this research currently enrolling participants?

"As indicated on clinicaltrials.gov, the trial in question is not currently accepting participants; it was first posted September 1st 2023 and last edited August 31st 2023. Nevertheless, there are 30 other active studies that are welcoming applicants to join them at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027619.

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