Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

NCT02124733 | Completed Phase 3

• 1 other identifier: 14-374
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Keywords

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

Outcome Measures

Primary Outcomes (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.

  at 3 months post-treatment

Secondary Outcomes (1)

• Pain during illumination

  During treatment through post-treatment Day4

Study Arms (3)

Group 1: 30 minutes

ACTIVE COMPARATOR

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

Group 2: 45 minutes

ACTIVE COMPARATOR

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

Group 3: 60 minutes

ACTIVE COMPARATOR

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

Interventions

Aminolevulinic acid based photodynamic therapy 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).

Also known as: Levulan® Kerastick™, Blu-U

Group 1: 30 minutes; Group 2: 45 minutes; Group 3: 60 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Edward Maytin, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluator assesses photographs without prior knowledge of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2018
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

US (1)