Skin Physiology, Dermal Administration, Emulsions
Conditions
Keywords
Water-in-oil emulsion, Confocal Raman spectroscopy, Skin parameters, Tape stripping
Brief 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.
Interventions
OTHERApplication of emulsion
Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks
PROCEDUREMeasurement of physiological skin parameters
Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®
PROCEDURETape stripping
Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss
Sponsors
Medical University of Vienna
University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of subject informed consent * Female or male aged between 18 and 65 years
Exclusion criteria
* Pregnancy * Chronic skin conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in transepidermal water loss | 6 weeks | Influence of the application of the water-in-oil emulsions with different oil component - isopropyl myristate (IPM) or liquid paraffin (PAR) - on the transepidermal water loss (TEWL) using the AquaFlux Model AF200 Evaporimeter |
| Penetrated amount of fluorescein sodium into the skin using tape stripping/fluorescence spectroscopy | week 8 | Enhancement of the skin penetration of the model drug fluorescein sodium by the oil component isopropyl myristate in vivo using tape stripping combined with fluorescence spectroscopy |
Countries
Austria
Outcome results
None listed