NCT01812837

The Use of Microneedles in Photodynamic Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses The specific aims are as follows: 1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc. 2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DEVICE	Microneedle	The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
DRUG	Aminolevulinic Acid	Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
RADIATION	Blue light	Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-03-18
• Last updated: 2017-06-15
• Results posted: 2017-01-30

Locations

1 site across 1 country: United States