Pretreatments of the Skin Prior to PDT

Study Overview
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Brief Summary
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The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT).

Detailed Description
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The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT). The pretreatments include: microneedling, sandpaper, curettage, ablative fractional laser and non-ablative fractional laser. 17 treatment areas are mapped on the upper back of the participants. Each participant receives each intervention in a random sequence. Primary outcome measure: PpIX accumulation after 3 hours incubation with MAL. Secondary outcome measures: pain during treatment and skin reactions.

Official Title
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Pretreatments of the Skin to Enhance MAL-induced Protoporphyrin IX (PpIX) Accumulation Prior to Photodynamic Therapy (PDT)

Conditions
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Healthy

Intervention / Treatment
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* Procedure: Microneedle pretreatment + MAL-PDT
* Procedure: Sandpaper pretreatment + MAL-PDT
* Procedure: Curettage pretreatment + MAL-PDT
* Procedure: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT
* Procedure: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT
* Drug: MAL Control.
* Other: Untreated Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older, healthy, fair skinned (skin type I-III) Exclusion Criteria: Pregnant women Tattoos, moles or scars in treatment area

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventions<br>All participants receive all interventions. | Procedure: Microneedle pretreatment + MAL-PDT<br>* Interventions: microneedling of the skin using dermarollers prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.<br>Procedure: Sandpaper pretreatment + MAL-PDT<br>* Interventions: abrasion of the skin using Abrasive Pads for Skin Preparation prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.<br>Procedure: Curettage pretreatment + MAL-PDT<br>* Interventions: curettage of the skin using a curette prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.<br>Procedure: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT<br>* Interventions: Ablative Fractional Laser (AFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.<br>Procedure: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT<br>* Interventions: Non-Ablative Fractional Laser (NAFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.<br>Drug: MAL Control.<br>* Intervention: Topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)).<br>Other: Untreated Control<br>* Untreated control. No interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protoporphyrin IX (PpIX) fluorescence | Protoporphyrin IX (PpIX) fluorescence as measured by a fluorescence camera (Medeikonos PDD/PDT, Medeikonos AB,Gothenburg, Sweden). | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain during treatment as measured by Visual Analog Scale. | Day 0 | 
| Skin reactions | Skin reactions evaluated on a clinical scale. | Day 0, Day 1, Day 3, Day 7 |