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The Use of Microneedles in Photodynamic Therapy

NCT01812837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-06-15

Study results available
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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

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)

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Raja K Sivamani, MD · UC Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01812837 on ClinicalTrials.gov