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Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aminolevulinic acid based photodynamic therapy
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Actinic Keratoses, AK, PDT, Photodynamic Therapy, Blue Light Therapy, ALA, aminolevulinic acid, Levulan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1: 30 minutes

Group 2: 45 minutes

Group 3: 60 minutes

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
April 25, 2014
Last Updated
October 9, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02124733
Brief Title
Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses
Official Title
Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis, Actinic Keratoses, AK, PDT, Photodynamic Therapy, Blue Light Therapy, ALA, aminolevulinic acid, Levulan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients with actinic keratosis of the face/scalp were enrolled for an intrapatient comparative study of two different regimens for delivering ALA-based PDT treatment. In this contralateral/bilateral study design, each patient served as his/her own control. One side of the face or scalp (Side B), the traditional control regimen of PDT was given (1 h topical drug then 16 min 40 sec of blue light). On the test side (Side A), we administered a new regimen; topical drug was applied and then the blue light immediately started. Three groups of patients (Study arms) had different times of exposure (either 30 min, 45 min, or 60 min). For all patients, the post-treatment course was compared for Sides A vs. B. The primary endpoints were pain during illumination, and lesion clearance at 3 months post-therapy.
Masking
Outcomes Assessor
Masking Description
Evaluator assesses photographs without prior knowledge of intervention
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: 30 minutes
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2: 45 minutes
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3: 60 minutes
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Aminolevulinic acid based photodynamic therapy
Other Intervention Name(s)
Levulan® Kerastick™, Blu-U
Intervention Description
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).
Primary Outcome Measure Information:
Title
AK clearance
Description
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.
Time Frame
at 3 months post-treatment
Secondary Outcome Measure Information:
Title
Pain during illumination
Description
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.
Time Frame
During treatment through post-treatment Day4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Maytin, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

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