Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2012-07-31
2014-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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20 minutes incubation - with pretreatment
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.
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
40 minutes incubation - with pretreatment
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.
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
60 minutes incubation - with pretreatment
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.
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
60 minutes incubation - no pretreatment
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
Interventions
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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.
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Raja K Sivamani, MD
Role: PRINCIPAL_INVESTIGATOR
UC Davis
Locations
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UC Davis, Dermatology
Sacramento, California, United States
Countries
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Related Links
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University of California-Davis Department of Dermatology Clinical Research
Other Identifiers
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282150
Identifier Type: -
Identifier Source: org_study_id
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