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The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

NCT02594644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-11-29

Study results available
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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.

Conditions

  • Keratosis, Actinic

Interventions

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

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Raja Sivamani, M.D. · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-06
Primary Completion
2016-06-22
Completion
2016-06-22

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 NCT02594644 on ClinicalTrials.gov