- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02124733
Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses
October 9, 2023 updated by: Edward Maytin, MD, PhD, The Cleveland Clinic
Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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).
Other Names:
|
Active Comparator: 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.
|
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).
Other Names:
|
Active Comparator: 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.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AK clearance
Time Frame: 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.
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at 3 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during illumination
Time Frame: 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.
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During treatment through post-treatment Day4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edward Maytin, MD, PhD, The Cleveland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
April 25, 2014
First Submitted That Met QC Criteria
April 25, 2014
First Posted (Estimated)
April 28, 2014
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 9, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-374
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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