NCT03327831

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid	Topical application followed by activation by ambient sunlight

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-02-01
• Completion: 2017-07-01
• First posted: 2017-10-31
• Last updated: 2024-06-27
• Results posted: 2024-06-27

Locations

1 site across 1 country: United States