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Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aminolevulinic Acid
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring aminolevulinic acid, pdt, photodynamic therapy, Photochemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Irvine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Treatment Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

The change in the number of Actinic Keratoses
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

Adverse events
Measurement of crusting, erythema, edema, and pain
Lux Correlation
Ambient lux from sunlight is measured during treatment and will be analyzed to determine if it contributes to treatment efficacy

Full Information

First Posted
October 23, 2015
Last Updated
December 13, 2017
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT03327831
Brief Title
Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Official Title
UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
aminolevulinic acid, pdt, photodynamic therapy, Photochemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label Treatment Arm
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Aminolevulinic Acid
Other Intervention Name(s)
Kerastick
Intervention Description
Topical application followed by activation by ambient sunlight
Primary Outcome Measure Information:
Title
The change in the number of Actinic Keratoses
Description
The the change in number of actinic keratoses at time 0 and 6 months treatment will be measured as the primary outcome
Time Frame
0, 3, and 6 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
Measurement of crusting, erythema, edema, and pain
Time Frame
0, 3, and 6 months
Title
Lux Correlation
Description
Ambient lux from sunlight is measured during treatment and will be analyzed to determine if it contributes to treatment efficacy
Time Frame
0, 3, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher B Zachary, MBBS. FRC[
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697-2400
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

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