Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified September 2023 by The Cleveland Clinic
Sponsor
The Cleveland Clinic
Information Provided by (Responsible Party)
Edward Maytin, MD, PhD
Clinicaltrials.gov Identifier
NCT02124733
Other Study ID Numbers:
14-374
First Submitted
April 24, 2014
First Posted
April 27, 2014
Last Update Posted
October 9, 2023
Last Verified
September 2023

ClinicalTrials.gov processed this data on October 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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

Condition or DiseaseIntervention/Treatment
Actinic Keratosis
Procedure: Aminolevulinic acid based photodynamic therapyProcedure: Aminolevulinic acid based photodynamic therapyProcedure: Aminolevulinic acid based photodynamic therapy

Study Design

Study TypeInterventional
Actual Enrollment23 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleSimultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses
Study Start DateMarch 31, 2014
Actual Primary Completion DateSeptember 30, 2016
Actual Study Completion DateNovember 30, 2018

Groups and Cohorts

Group/CohortIntervention/Treatment
Group 1: 30 minutes
The first 4 patients enrolled will be considered Group 1, and will receive 30 min of Aminolevulinic acid based photodynamic therapy to Side A. They will be evaluated in terms of erythema immediately post-PDT (Day 1) and on Day 4 . If there is no clinical reaction on Side A after 2 patients, then the dose will be advanced to the next Group. If the post-PDT reaction (erythema at Day 4) on Side A equals or exceeds the reaction on Side B in the majority of the first 4 patients, then the dose will not be escalated and recruitment will continue until 15 patients have been treated (thereby completing the study). If the post-PDT reaction on Side A is less than the reaction on Side B in the majority of the 4 patients, then the protocol will advance to Group 2
Procedure: Aminolevulinic acid based photodynamic therapy
The PDT treatments will be done in two stages. ALA (Levulan® Kerastick™) will be applied to the entire treatment area, and then the longer light exposure (lasting up to 1 hr) will be performed on one-half of the treatment area (Side A). After that, a shorter (16 min 40 sec) light exposure will be done on the other half (Side B).
Group 2: 45 minutes
Patients in this group will receive 45 min of Aminolevulinic acid based photodynamic therapy to Side A. They will be evaluated for erythema response immediately post-PDT and at Day 4. If there is no clinical reaction on Side A after 2 patients, then the dose will be advanced to the next Group. If the post-PDT reaction (erythema at Day 4) on Side A equals or exceeds the reaction on Side B in the majority of the first 4 patients, then the dose will not be escalated and recruitment will continue until 15 patients have been treated (thereby completing the study). If the post-PDT reaction on Side A is less than the reaction on Side B in the majority of the 4 patients, then the protocol will advance to Group 3.
Procedure: Aminolevulinic acid based photodynamic therapy
The PDT treatments will be done in two stages. ALA (Levulan® Kerastick™) will be applied to the entire treatment area, and then the longer light exposure (lasting up to 1 hr) will be performed on one-half of the treatment area (Side A). After that, a shorter (16 min 40 sec) light exposure will be done on the other half (Side B).
Group 3: 60 minutes
Patients in this group will receive 60 min of Aminolevulinic acid based photodynamic therapy to Side A. They will be evaluated for erythema responses immediately post-PDT and at Day 4. If the post-PDT reaction on Side A equals or exceeds the reaction on Side B in the majority of the first 4 patients, then the dose will not be escalated and recruitment will continue until 15 patients have been treated (thereby completing the study). If the post-PDT reaction on Side A is less than the reaction on Side B in the majority of patients, then the protocol will terminate after 15 patients (total for all groups) have been treated.
Procedure: Aminolevulinic acid based photodynamic therapy
The PDT treatments will be done in two stages. ALA (Levulan® Kerastick™) will be applied to the entire treatment area, and then the longer light exposure (lasting up to 1 hr) will be performed on one-half of the treatment area (Side A). After that, a shorter (16 min 40 sec) light exposure will be done on the other half (Side B).

Outcome Measures

Primary Outcome Measures
  1. AK clearance
    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
  1. Pain during illumination
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsThe Cleveland Clinic
Locations
Cleveland Clinic | Cleveland Ohio, United States, 44195
Investigators
Principal Investigator: Edward Maytin, MD, PhD, The Cleveland Clinic