Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Irvine
• Treatments: Aminolevulinic Acid

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