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OpenTrials
Completed

NCT Number: NCT01812837

The Use of Microneedles in Photodynamic Therapy

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic 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

UC Davis, Dermatology

Sacramento, California, 95864, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who are 18 and older
  • Subjects who have at least 3 actinic keratoses on each side of the forehead
  • Subjects who signed an IRB approved informed consent

Exclusion criteria

  • Subjects who smoke
  • Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
  • Subjects who received a diagnosis of skin cancer on the face in past year
  • Subjects who received field treatment for actinic keratoses to the face in the past 60 days

Treatment and study plan

Microneedle

Device

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.

Other names: Microchannles

Aminolevulinic Acid

Drug

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

Blue light

Radiation

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

Primary outcomes

  1. Actinic Keratoses Reduction Percent

    Time frame: one month after treatment

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 18, 2013
Registry last updated
Jun 15, 2017

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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