The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Study Overview
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Brief Summary
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The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Detailed Description
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The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group. The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Official Title
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The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Conditions
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Keratosis, Actinic

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Subjects has actinic keratoses and qualifies for photodynamic therapy Do not meet any of the exclusion criteria Exclusion Criteria: Subjects who smoke Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition Subjects who have established allergy to topical ALA Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months

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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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10-minute Incubation with Microneedle Roller & Sham<br>10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows. | Device: Microneedle Roller<br>* The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.<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>|
| Experimental: 20-minute Incubation with Microneedle Roller & Sham<br>20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows. | Device: Microneedle Roller<br>* The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.<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 |
| --- | --- | --- |
| Difference in the Percentage of Complete Clearance of the Actinic Keratoses | The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups. | Baseline, 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | Immediately Post-Treatment |