MedDataX Logo

Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

NCT ID: NCT02124733

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Actinic Keratosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Actinic Keratosis Actinic Keratoses AK PDT Photodynamic Therapy Blue Light Therapy ALA aminolevulinic acid Levulan

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Evaluator assesses photographs without prior knowledge of intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Aminolevulinic acid based photodynamic therapy

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Aminolevulinic acid based photodynamic therapy

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Aminolevulinic acid based photodynamic therapy

Intervention Type PROCEDURE

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Levulan® Kerastick™ Blu-U

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Edward Maytin, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward Maytin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-374

Identifier Type: -

Identifier Source: org_study_id