The Use of Microneedles in Photodynamic Therapy

May 24, 2017 updated by: University of California, Davis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95864
        • UC Davis, Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20 minutes incubation - with pretreatment
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.
Other Names:
  • Microchannles
Drug: Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Radiation: Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
Experimental: 40 minutes incubation - with pretreatment
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.
Other Names:
  • Microchannles
Drug: Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Radiation: Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
Experimental: 60 minutes incubation - with pretreatment
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.
Other Names:
  • Microchannles
Drug: Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Radiation: Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
Sham Comparator: 60 minutes incubation - no pretreatment
Drug: Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Radiation: Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Actinic Keratoses Reduction Percent
Time Frame: one month after treatment
one month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Actinic Keratosis

Clinical Trials on Microneedle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe