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OpenTrials
Completed

NCT Number: NCT02594644

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

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.

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Key information

Conditions

Keratosis, Actinic Keratosis Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microneedle Roller

Device

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

Aminolevulinic Acid

Drug

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

Blue light

Radiation

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

Primary outcomes

  1. Difference in the Percentage of Complete Clearance of the Actinic Keratoses

    Time frame: Baseline, 2 Months

    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.

Secondary outcomes

  1. Visual Analog Pain Scale

    Time frame: Immediately Post-Treatment

    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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2015
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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