Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

NCT ID: NCT03327831

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-07-31

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

Conditions

Actinic Keratosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aminolevulinic Acid with daylight photodynamic therapy 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.

Group Type: EXPERIMENTAL

Aminolevulinic Acid

Intervention Type: DRUG

Topical application followed by activation by ambient sunlight

Interventions

Aminolevulinic Acid

Topical application followed by activation by ambient sunlight

Intervention Type: DRUG

Other Intervention Names

Kerastick

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Christopher Zachary

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher B Zachary, MBBS. FRC[

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20151889

Identifier Type: -

Identifier Source: org_study_id