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Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

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ClinicalTrials.gov Identifier: NCT03327831
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Aminolevulinic Acid Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Study Start Date : April 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : July 2017

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Aminolevulinic Acid
Topical application followed by activation by ambient sunlight
Other Name: Kerastick


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Adverse events [ Time Frame: 0, 3, and 6 months ]
    Measurement of crusting, erythema, edema, and pain

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327831


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92697-2400
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Christopher B Zachary, MBBS. FRC[ University of California, Irvine
More Information
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Responsible Party: Christopher Zachary, Principal Investigator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03327831    
Other Study ID Numbers: 2015-1889
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christopher Zachary, University of California, Irvine:
aminolevulinic acid
pdt
photodynamic therapy
Photochemotherapy
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
 Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents