Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Study Overview
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Brief Summary
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Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.

Detailed Description
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Initial Visit: study inclusion criteria reviewed consent forms reviewed creation of facial map for actinic keratoses face cleansed with chlorhexidine soap light curettage of precancerous skin lesions application of topical aminolevulinic acid (ALA) application of sunscreen patient then spends 2 hours outdoors in a shaded area after treatment the patient is to remain indoors for 48 hours 3 month follow up visit - facial map of actinic keratoses used to document treatment response 6 month follow up visit facial map of actinic keratoses used to document treatment response

Official Title
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UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Aminolevulinic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of >10 actinic keratoses on head and neck Age ≥ 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study) Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Patients currently undergoing anti-neoplastic therapy including but not limited to the following: Topical imiquimod Topical 5-fluorouracil Topical ingenol mebutate Topical diclofenac Topical retinoids Oral acitretin History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid Patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease. Patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines. pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Treatment Arm<br>This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. | Drug: Aminolevulinic Acid<br>* Topical application followed by activation by ambient sunlight<br>* Other names: Kerastick;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the number of Actinic Keratoses | The the change in number of actinic keratoses at time 0 and 6 months treatment will be measured as the primary outcome | 0, 3, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Measurement of crusting, erythema, edema, and pain | 0, 3, and 6 months | 
| Lux Correlation | Ambient lux from sunlight is measured during treatment and will be analyzed to determine if it contributes to treatment efficacy | 0, 3, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pdt, aminolevulinic acid, photodynamic therapy, Photochemotherapy