The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

University of California, Davis32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Keratosis, Actinic

Interventions

Microneedle RollerDEVICE

The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.

Aminolevulinic AcidDRUG

Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue LightRADIATION

Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age and older * Subjects has actinic keratoses and qualifies for photodynamic therapy * Do not meet any of the exclusion criteria Exclusion Criteria: * Subjects who smoke * Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition * Subjects who have established allergy to topical ALA * Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months

Locations (1)

University of California-Davis, Department of Dermatology

Sacramento, California, United States

Outcomes

Primary Outcomes

Difference in the Percentage of Complete Clearance of the Actinic Keratoses

The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.

Time frame: Baseline, 2 Months

Secondary Outcomes

Visual Analog Pain Scale

The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Time frame: Immediately Post-Treatment

Data from ClinicalTrials.gov

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