PDT vs Peels for AKs

Study Overview
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Brief Summary
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The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities. This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Official Title
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PDT Versus the Combination of Jessner's Solution and 35% TCA for Treatment of Actinic Keratoses on Upper Extremities: A Randomized Controlled Split-arm Trial

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Procedure: Photodynamic Therapy
* Drug: Chemical Peels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Interested in receiving treatment for actinic keratoses on the bilateral upper arms In good general health as assessed by the investigator Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: Patient pregnant or nursing Patient with extensive concurrent skin conditions (such as eczema, psoriasis, etc) on upper extremities that would interfere with treatment as determined by the treating physician Subject unwilling to sign an IRB approved consent form Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

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 |
| --- | --- |
| Active Comparator: Photodynamic Therapy<br>One upper arm will be exposed to blue light therapy | Procedure: Photodynamic Therapy<br>* Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)<br>* Other names: PDT;|
| Active Comparator: Chemical Peels<br>One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel | Drug: Chemical Peels<br>* Chemical peels consists of a combination of Jessner's Solution: Composed of Salicylic Acid (14%), Medical Grade Lactic Acid (14%), Medical Grade Resorcinol (14%), Denatured Ethyl Alcohol AND 35% Trichloroacetic acid peels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of total AKs cleared | Percentage of total AKs cleared will be calculated by counting the number of AKs before treatment and 2-8 weeks after treatments. | 2-8 weeks after treatments |