Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

Phase 3

Completed

• Conditions: Actinic Keratosis

• Registration Number: NCT02124733
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.

Detailed Description

This study is being done to compare a modified version of the standard ALA-PDT (Aminolevulinate-Photodynamic Therapy) treatment of actinic keratoses, to a modified version in which light exposure begins immediately after application of the Levulan. We hypothesize that this will yield a therapeutic efficacy equivalent to the standard ALA-PDT regimen, but will cause less pain during the light exposure. The study employs a bilateral design in which the left versus right sides of the treatment area are compared in the exact same patient. There are 3 arms of the study, each having a different time duration of light exposure in the modified regimen to determine which one is most efficacious

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-28
• Primary Completion: 2016-10
• Study Completion: 2018-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Males or females, at least 18 years of age
• Non-hyperkeratotic actinic keratoses, at least 6 in number (3 on each side of scalp, face or upper extremities)

Exclusion Criteria

• patient is currently pregnant or are planning to conceive during the course of the study period
• patient is using topical therapy or other treatment for these actinic keratoses
• patient has a known hypersensitivity to 5-aminolevulinic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AK clearance	at 3 months post-treatment	The primary endpoint is treatment efficacy (AK lesion clearance at 3 months). The specific aim of this study is to establish proof-of-principle for the concept that a long delivery period of blue light from the Blu-U device, using the standard fluence rate but starting only 15 min after the application of Levulan and lasting 1 hour (fluence of 360 J/cm2), can provide a clearance rate of AK lesions comparable to a standard regimen of Blu-U light (fluence of 10 J/cm2) beginning 1 hr after LevulanTM application.

Secondary Outcome Measures

Name	Time	Method
Pain during illumination	During treatment through post-treatment Day4	The secondary endpoint is pain during illumination. The hypothesis is that efficacy at 3 months will be statistically equivalent with the two approaches, but pain will be significantly less with the continuous treatment regimen.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States