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.

• 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

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