The Use of Microneedles in Photodynamic Therapy

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Microneedles in Photodynamic Therapy

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Device: Microneedle
* Drug: Aminolevulinic Acid
* Radiation: Blue light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 minutes incubation - with pretreatment<br> | Device: Microneedle<br>* 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.<br>* Other names: Microchannles;Drug: Aminolevulinic Acid<br>* Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA<br>Radiation: Blue light<br>* Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)<br>|
| Experimental: 40 minutes incubation - with pretreatment<br> | Device: Microneedle<br>* 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.<br>* Other names: Microchannles;Drug: Aminolevulinic Acid<br>* Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA<br>Radiation: Blue light<br>* Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)<br>|
| Experimental: 60 minutes incubation - with pretreatment<br> | Device: Microneedle<br>* 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.<br>* Other names: Microchannles;Drug: Aminolevulinic Acid<br>* Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA<br>Radiation: Blue light<br>* Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)<br>|
| Sham Comparator: 60 minutes incubation - no pretreatment<br> | Drug: Aminolevulinic Acid<br>* Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA<br>Radiation: Blue light<br>* Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actinic Keratoses Reduction Percent |  | one month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratosis, microneedles, photodynamic therapy, levulan, Aminolevulinic acid