Photodynamic Therapy Incubation Times for Actinic Keratosis

Study Overview
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Brief Summary
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This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis. Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks. This study is a pilot study designed to determine feasibility of this procedure.

Official Title
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A Randomized Controlled Trial Evaluating 5-aminolevulinic Acid Photodynamic Therapy With Different Incubation Times for the Treatment of Actinic Keratosis

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: ALA (5-aminolevulinic acid)
* Device: Blue light therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have been diagnosed with actinic keratosis. Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp. Males or females ≥ 18 years old Fitzpatrick skin types I-VI Subjects are in good health as judged by the investigator. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator. Exclusion criteria: Subjects who by the investigator are not suitable for photodynamic therapy. Lesions suspicious or proven for skin cancer History of 2 or more ALA- PDT treatments within the past 6 months. Use of keratolytics within 2 days of initiation of treatment (e.g., >5% urea, glycolic acid, lactic acid, salicyclic acid) Cryotherapy within the past 2 weeks. Topical retinoids within the past 4 weeks Procedures, such as microdermabrasion, ablative lasers, ALA-PDT, chemical peels, 5-fluorouraci, diclofenac, imiquimod within the past 8 weeks Systemic retinoids within the past 6 months Pregnant or breast feeding Uncooperative subjects or subjects with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. Subjects who are unable to understand the protocol or give informed consent. Subjects who in the opinion of the investigator are not suitable for the study.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zero incubation with ALA (5-aminolevulinic acid)<br>Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. | Drug: ALA (5-aminolevulinic acid)<br>* ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation<br>* Other names: Levulon kerastick;Device: Blue light therapy<br>* Subjects will be exposed to blue light<br>* Other names: BLU-U® Blue Light Photodynamic Therapy Illuminator;|
| Experimental: One hour incubation with ALA (5-aminolevulinic acid)<br>Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. | Drug: ALA (5-aminolevulinic acid)<br>* ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation<br>* Other names: Levulon kerastick;Device: Blue light therapy<br>* Subjects will be exposed to blue light<br>* Other names: BLU-U® Blue Light Photodynamic Therapy Illuminator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of Actinic Keratosis (AK) lesions | The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit. | Baseline and 8 Weeks |