Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

Study Overview
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Brief Summary
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The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.

Official Title
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A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Keratoses on the Face

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: ALA
* Drug: Topical Solution Vehicle
* Device: IBL 10 mW
* Procedure: Microneedle lesion preparation
* Device: IBL 20 mW


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Four to eight AKs on the face Exclusion Criteria: Pregnancy history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy Subject is immunosuppressed currently enrolled in an investigational drug or device study has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face use of the following topical preparations on the extremity to be treated: Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days Curettage or Cryotherapy within 2 weeks of initiation of treatment Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks use of systemic retinoid therapy within 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALA 25 min 10 Milliwatts (mW)<br>ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light (IBL);|
| Experimental: MN + ALA 25 min 10 mW<br>Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light (IBL);Procedure: Microneedle lesion preparation<br>* Microneedling of all visible/palpable AK lesions prior to solution application.<br>|
| Experimental: ALA 25 min 20 mW<br>ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Device: IBL 20 mW<br>* 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds<br>* Other names: Investigational Blue Light;|
| Experimental: MN + ALA 25 min 20 mW<br>Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Procedure: Microneedle lesion preparation<br>* Microneedling of all visible/palpable AK lesions prior to solution application.<br>Device: IBL 20 mW<br>* 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds<br>* Other names: Investigational Blue Light;|
| Experimental: ALA 60 min 10 mW<br>ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light (IBL);|
| Experimental: MN + ALA 60 min 10 mW<br>Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light (IBL);Procedure: Microneedle lesion preparation<br>* Microneedling of all visible/palpable AK lesions prior to solution application.<br>|
| Experimental: ALA 60 min 20 mW<br>ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Device: IBL 20 mW<br>* 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds<br>* Other names: Investigational Blue Light;|
| Experimental: MN + ALA 60 min 20 mW<br>Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. | Drug: ALA<br>* 20% ALA applied to face prior to light treatment<br>* Other names: Aminolevulinic acid;Procedure: Microneedle lesion preparation<br>* Microneedling of all visible/palpable AK lesions prior to solution application.<br>Device: IBL 20 mW<br>* 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds<br>* Other names: Investigational Blue Light;|
| Placebo Comparator: VEH<br>Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. | Drug: Topical Solution Vehicle<br>* Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment<br>Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light (IBL);|
| Placebo Comparator: MN + VEH<br>Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. | Drug: Topical Solution Vehicle<br>* Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment<br>Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light (IBL);Procedure: Microneedle lesion preparation<br>* Microneedling of all visible/palpable AK lesions prior to solution application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance Rate | Number of AK Fields with 0 lesions | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance Rate | Number of AK Fields with 0 Lesions | Week 8 | 
| Subject Satisfaction Score | Subject satisfaction score = Excellent (very satisfied) = Good (moderately satisfied) = Fair (slightly satisfied) = Poor (not satisfied at all) | Week 12 | 
| Baseline AKCR | AK clearance rate (AKCR) for only those lesions present at Baseline | Baseline and Week 8 | 
| Baseline AKCR | AK clearance rate for only those lesions present at Baseline | Baseline and Week 12 | 
| Percent Change | Percent change in the total AK number as compared with Baseline | Baseline and Week 8 | 
| Percent Change | Percent change in the total AK number as compared with Baseline | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis