Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

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

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.

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

• 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

Arms and Interventions

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

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

• 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

Locations

United States, California

University of California, Irvine

Irvine, California, United States, 92697-2400

Sponsors and Collaborators

University of California, Irvine

Investigators

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

More Information

• 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
• 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:

Keratosis, Actinic; Keratosis; Skin Diseases; Precancerous Conditions; Neoplasms; Aminolevulinic Acid; Photosensitizing Agents; Dermatologic Agents