Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Aminolevulinic Acid

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: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697-2400
      • University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Kerastick

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0, 3, and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Christopher B Zachary, MBBS. FRC[, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: photodynamic therapy; Photochemotherapy; aminolevulinic acid; pdt
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 2015-1889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO