NCT03876639

Topical Application of Highly Concentrated Water-in-oil Emulsions

Topical Application of Highly Concentrated Water-in-oil Emulsions: Physiological Skin Parameters and Skin Penetration in Vivo - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to I. determine the effect of repetitive application of newly developed silicone based formulations (placebo water-in-oil emulsions) on transepidermal water loss and other physiological skin parameters and II. investigate the skin penetration of the model drug fluorescein sodium in tape stripping studies to determine the in vivo penetration profile from the water-in-oil emulsions.

Detailed description

Water-in-oil emulsions will be applied daily for a period of 4 weeks on the non-dominant volar forearm of voluntary participants. Several physiological skin parameters will be monitored in weekly intervals during the application period. Additional measurements will be carried out immediately before the start of the application and after a treatment-free recovery period of 2 weeks. The untreated forearm will be used as a reference. Subsequent to the observational study, tape stripping experiments with fluorescein sodium-loaded formulations will be conducted on the non-dominant forearm of the participants.

Conditions

• Skin Physiology
• Dermal Administration
• Emulsions

Interventions

Type	Name	Description
OTHER	Application of emulsion	Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks
PROCEDURE	Measurement of physiological skin parameters	Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®
PROCEDURE	Tape stripping	Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss

Timeline

• Start date: 2019-01-16
• Primary completion: 2019-03-18
• Completion: 2019-03-18
• First posted: 2019-03-15
• Last updated: 2019-04-17

Locations

1 site across 1 country: Austria