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The Use of Microneedles in Photodynamic Therapy

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ClinicalTrials.gov Identifier: NCT01812837
Recruitment Status : Completed
First Posted : March 18, 2013
Results First Posted : January 30, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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:

  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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Device: Microneedle Drug: Aminolevulinic Acid Radiation: Blue light Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Microneedles in Photodynamic Therapy
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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Arms and Interventions
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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 Name: 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 Name: 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 Name: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Actinic Keratoses Reduction Percent [ Time Frame: one month after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812837


Locations
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United States, California
UC Davis, Dermatology
Sacramento, California, United States, 95864
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja K Sivamani, MD UC Davis
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01812837    
Other Study ID Numbers: 282150
First Posted: March 18, 2013    Key Record Dates
Results First Posted: January 30, 2017
Last Update Posted: June 15, 2017
Last Verified: May 2017
Keywords provided by University of California, Davis:
actinic keratosis
microneedles
photodynamic therapy
levulan
Aminolevulinic acid
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
 Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents