Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Microneedles pretreatment; Drug: METVIXIA Cream; Other: occlusive bandage; Device: ablative fractional CO2 laser pretreatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 29, 2015

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: volunteers
• Additional Relevant MeSH Terms: Photosensitizing Agents; Dermatologic Agents; Methyl 5-aminolevulinate
• Other Study ID Numbers: RD.03.SPR.40221E; 2013-003371-35 (EudraCT Number)