Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

University of California Irvine (UCI)

Status and phase: Completed; Phase 4

Conditions: Actinic Keratosis

Treatments: Drug: Aminolevulinic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03327831

20151889

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Aminolevulinic Acid with daylight photodynamic therapy arm

Experimental group

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.

Treatment:

Drug: Aminolevulinic Acid