Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- AK clearance
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Evaluator assesses photographs without prior knowledge of intervention
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pain during illumination(During treatment through post-treatment Day4)
Investigators
Edward Maytin, MD, PhD
MD, PhD
The Cleveland Clinic