NCT02594644

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Detailed description

The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group. The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DEVICE	Microneedle Roller	The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.
DRUG	Aminolevulinic Acid	Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
RADIATION	Blue Light	Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Timeline

• Start date: 2014-11-06
• Primary completion: 2016-06-22
• Completion: 2016-06-22
• First posted: 2015-11-03
• Last updated: 2018-11-29
• Results posted: 2018-11-29

Locations

1 site across 1 country: United States