Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-07-08

Brief Summary

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The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are:

* Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance?
* Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance?
* Will the new test regimens achieve reduced pain during illumination?
* Will the new test regimens be safe?

Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regimen A

Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source

Group Type EXPERIMENTAL

Topical aminolevulinate (10% ALA gel)

Intervention Type DRUG

10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period

Red light illumination

Intervention Type DEVICE

Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Regimen B

Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source

Group Type EXPERIMENTAL

Topical aminolevulinate (10% ALA gel)

Intervention Type DRUG

10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period

Red light illumination

Intervention Type DEVICE

Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Regimen C

Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source

Group Type EXPERIMENTAL

Topical aminolevulinate (10% ALA gel)

Intervention Type DRUG

10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period

Red light illumination

Intervention Type DEVICE

Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Interventions

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Topical aminolevulinate (10% ALA gel)

10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period

Intervention Type DRUG

Red light illumination

Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Intervention Type DEVICE

Other Intervention Names

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Ameluz gel, 10% aminolevulinic acid BF-RhodoLED® Light Source

Eligibility Criteria

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Inclusion Criteria

* Minimum of 10 actinic keratoses lesions on the face.
* Female subjects must not become pregnant during the study
* Subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

* Pregnant or nursing.
* Using any topical treatment on their AKs; must stop at least one month prior.
* Currently undergoing treatment for other cancers with medical or radiation therapy.
* Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
* Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No