Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2017

Detailed Description

– 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

Interventions

  • Drug: Aminolevulinic Acid
    • Topical application followed by activation by ambient sunlight

Arms, Groups and Cohorts

  • Experimental: Open Label Treatment Arm
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The change in the number of Actinic Keratoses
    • Time Frame: 0, 3, and 6 months
    • The the change in number of actinic keratoses at time 0 and 6 months treatment will be measured as the primary outcome

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, Irvine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christopher Zachary, Principal Investigator – University of California, Irvine
  • Overall Official(s)
    • Christopher B Zachary, MBBS. FRC[, Principal Investigator, University of California, Irvine

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