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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

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE October 31, 2017
Last Update Posted Date December 15, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Official Title  ICMJE UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Actinic Keratosis
Intervention  ICMJE Drug: Aminolevulinic Acid
Topical application followed by activation by ambient sunlight
Other Name: Kerastick
Study Arms  ICMJE 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.
Intervention: Drug: Aminolevulinic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2017)
31
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327831
Other Study ID Numbers  ICMJE 2015-1889
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Zachary, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher B Zachary, MBBS. FRC[ University of California, Irvine
PRS Account University of California, Irvine
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP