Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Procedure: Aminolevulinic acid based photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02124733

14-374

Details and patient eligibility

About

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.

Full 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

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 3 patient groups

Group 1: 30 minutes

Active Comparator group

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

Treatment:

Procedure: Aminolevulinic acid based photodynamic therapy

Group 2: 45 minutes

Active Comparator group

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.

Treatment:

Procedure: Aminolevulinic acid based photodynamic therapy

Group 3: 60 minutes

Active Comparator group

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.

Treatment:

Procedure: Aminolevulinic acid based photodynamic therapy