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The Use of Microneedles in Photodynamic Therapy

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microneedle
Aminolevulinic Acid
Blue light
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring actinic keratosis, microneedles, photodynamic therapy, levulan, Aminolevulinic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UC Davis, Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

20 minutes incubation - with pretreatment

40 minutes incubation - with pretreatment

60 minutes incubation - with pretreatment

60 minutes incubation - no pretreatment

Arm Description

Outcomes

Primary Outcome Measures

Actinic Keratoses Reduction Percent

Secondary Outcome Measures

Full Information

First Posted
March 13, 2013
Last Updated
May 24, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01812837
Brief Title
The Use of Microneedles in Photodynamic Therapy
Official Title
The Use of Microneedles in Photodynamic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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: Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
actinic keratosis, microneedles, photodynamic therapy, levulan, Aminolevulinic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 minutes incubation - with pretreatment
Arm Type
Experimental
Arm Title
40 minutes incubation - with pretreatment
Arm Type
Experimental
Arm Title
60 minutes incubation - with pretreatment
Arm Type
Experimental
Arm Title
60 minutes incubation - no pretreatment
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Microneedle
Other Intervention Name(s)
Microchannles
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aminolevulinic Acid
Intervention Description
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Intervention Type
Radiation
Intervention Name(s)
Blue light
Intervention Description
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
Primary Outcome Measure Information:
Title
Actinic Keratoses Reduction Percent
Time Frame
one month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja K Sivamani, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis, Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95864
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research

Learn more about this trial

The Use of Microneedles in Photodynamic Therapy

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