NCT02511145

Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	occlusive bandage
DEVICE	ablative fractional CO2 laser pretreatment
DEVICE	Microneedles pretreatment
DRUG	METVIXIA Cream

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2015-07-29
• Last updated: 2015-07-31