Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

Study Overview
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Brief Summary
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Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy volunteers to compare the effect on MAL penetration into the skin following various mechanical penetration enhancement techniques.

Detailed Description
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At baseline, each mini-zone was selected and randomly assigned to a pretreatment: 3 zones with microneedling Dermaroller®, 3 zones with ablative fractional CO2 Laser, and 3 zones with no pretreatment. After performing pretreatment, MAL cream was applied on the 6 assigned mini-zones for 3 hours incubation. Each condition was tested with and without occlusion. The three mini-zones with no product applied were used to perform biophysics measures.

Official Title
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Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration

Conditions
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Healthy

Intervention / Treatment
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* Other: occlusive bandage
* Device: ablative fractional CO2 laser pretreatment
* Device: Microneedles pretreatment
* Drug: METVIXIA Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of non childbearing potential, who is at least 18 years of age or older at screening visit. The subject has a skin phototype of I to III on Fitzpatrick's scale (Fitzpatrick et al., 1993) at screening visit. Subject should have 9 mini zone areas on the back that will be able to receive pre-treatments according to protocol. (checked at Screening visit, and assigned at Baseline visit) Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening visit, without any other medical reason], hysterectomy or bilateral oophorectomy). Exclusion Criteria: Subject with porphyria, Subject with past history of skin cancer, or current clinical diagnosis of other skin disease (including non-melanoma skin cancer), or tattoos, or cheloid and hypertrophic scars on the test zones, which, in the opinion of the investigator, might interfere with the interpretation of the clinical results, Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial. Known or suspected allergies or sensitivities to any components of any of the study drugs (see Product label). The subject has received, applied or taken some specific treatments within specified time frame prior to the baseline visit

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microneedles pretreatment and Metvixia<br>minizone with Microneedles pretreatment and Metvixia cream application | Device: Microneedles pretreatment<br> <br> * Other names: Dermaroller;Drug: METVIXIA Cream<br> <br> * Other names: MAL;|
| Active Comparator: Microneedles pretreatment and Metvixia under occlusion<br>minizone with Microneedles pretreatment and Metvixia cream application with occlusion | Other: occlusive bandage<br> <br> Device: Microneedles pretreatment<br> <br> * Other names: Dermaroller;Drug: METVIXIA Cream<br> <br> * Other names: MAL;|
| Active Comparator: Laser pretreatment and Metvixia<br>minizone with laser pretreatment and Metvixia cream application | Device: ablative fractional CO2 laser pretreatment<br> <br> Drug: METVIXIA Cream<br> <br> * Other names: MAL;|
| Active Comparator: Laser pretreatment and Metvixia under occlusion<br>minizone with Laser pretreatment and Metvixia cream application with occlusion | Other: occlusive bandage<br> <br> Device: ablative fractional CO2 laser pretreatment<br> <br> Drug: METVIXIA Cream<br> <br> * Other names: MAL;|
| Active Comparator: Metvixia<br>minizone with Metvixia cream application, without pretreatment | Drug: METVIXIA Cream<br> <br> * Other names: MAL;|
| Active Comparator: Metvixia under occlusion<br>minizone with Metvixia cream application under occlusion, without pretreatment | Other: occlusive bandage<br> <br> Drug: METVIXIA Cream<br> <br> * Other names: MAL;|
| Experimental: Microneedles pretreatment only<br>minizone with Microneedles pretreatment only | Device: Microneedles pretreatment<br> <br> * Other names: Dermaroller;|
| Experimental: Laser pretreatment only<br>minizone with Laser pretreatment only | Device: ablative fractional CO2 laser pretreatment<br> <br> |
| No Intervention: Normal skin<br>Normal skin control mini-zone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluorescence of protoporphyrin IX (PpIX) |  | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteers