Clinical trial NCT03327831
Conditions: Actinic Keratosis
Keywords: aminolevulinic acid pdt photodynamic therapy Photochemotherapy
Sponsor: University of California, Irvine
Start date: 2015-04-01; Completion date: 2017-07-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

Arms: arm 1: 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.
Interventions: intervention 1: Aminolevulinic Acid
Intervention descriptions: intervention 1: Topical application followed by activation by ambient sunlight

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
 
 
Official title of study: UCI 14-92 / HS #2015- 1889: Phase IV Study of Daylight Photodynamic Therapy 
with Aminolevulinic Acid for Actinic Keratoses 
NCT Number: NCT03327831 
Date of Document: July 1,2015 
 


 
Protocol/Methods: 
The study was designed prospectively to have 90% power to detect a 50% change in number of 
AKs. The study was approved by the University of California Institutional Review Board. A total 
of 30 patients were recruited from July 2015-October 2016 at the University of California, Irvine 
Department of Dermatology. Two patients were lost to follow up. Study inclusion criteria were 
age >18 years old with >10 actinic keratoses measuring >3mm each on the face or scalp. 
Exclusion criteria were history of photosensitive skin disorder, current pregnancy, or use of 
topical or oral retinoids, imiquimod, ingenol mebutate, fluorouracil, or photosensitizing 
medications in the past 3 months prior to PDT or during the 6 month study period. Patients were 
also excluded if the weather was rainy on the intended day of treatment. 
Patients were instructed to wash their faces using a washcloth with warm, soapy water for 5 
minutes in order to remove excess oil and improve drug penetration and then gently curetted 
with a 4mm non-disposable curette. 
After curettage, the ALA (Kerastick®, DUSA) was applied first as spot treatment to the individual 
lesions and then as field treatment to the entire treatment area. Following ALA application, an 
avobenzone-containing chemical sunscreen was applied. The chemical sunscreen was utilized 
to block ultraviolet light (and possible sunburn from daylight exposure) while allowing 
wavelengths above 400nm to pass through and activate the PpIX. 
After application patients were sent outdoors or home with a handheld luxometer (Suncheck 
Instruments, Model HS1010) and detailed written instructions. All patients were instructed to 
begin their daylight exposure within 30 minutes of ALA application and to remain in the daylight 
for 2 hours. We specifically asked patients to be in a shaded area “where you can see the sky 
but not the sun.” During daylight exposure, patients recorded pain (scale of 0-10), lux, the 
weather (raining, cloudy, partly cloudy, sunny) at times 0, 1 hour, and 2 hours, and patient 


satisfaction (not satisfied, slightly satisfied, moderately satisfied, or very satisfied). After daylight 
exposure all patients were instructed to apply physical sunscreen with titanium or zinc oxide and 
a wide brimmed hat in order to block visible light and prevent further PPIX activation. The 
patients were not instructed to wash off the ALA afterward. They were instructed to go indoors 
for the following 48 hours. All patients were given prophylactic valacyclovir 500 mg BID for 7 
days to prevent herpes simplex reactivation and possible eczema herpeticum. 
Patients were evaluated and photographed at time 0 days, 3 days, 3 months, and 6 months 
after treatment and AK counts were performed at 0 days, 3 months, and 6 months. Summary 
statistics were calculated and a Pearson correlation coefficient test was performed (Stata/IC, 
Version 15) to assess the relationship between lux received and AK count at 6 months.