Clinical trial NCT03327831: Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Official title: UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Keywords: aminolevulinic acid
pdt
photodynamic therapy
Photochemotherapy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Percent Change in the Number of Actinic Keratoses
timeFrame: 0 (baseline) and 6 months
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 2 days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Christopher B Zachary, MBBS. FRC[
role: PRINCIPAL_INVESTIGATOR
References: