Topical Application of Highly Concentrated Water-in-oil Emulsions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Emulsions, Skin Physiology, Dermal Administration

Intervention / Treatment
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* Other: Application of emulsion
* Procedure: Measurement of physiological skin parameters
* Procedure: Tape stripping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of subject informed consent Female or male aged between 18 and 65 years Exclusion Criteria: Pregnancy Chronic skin conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPM_2/18<br>Application of formulation IPM_2/18 | Other: Application of emulsion<br>* Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks<br>Procedure: Measurement of physiological skin parameters<br>* Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®<br>Procedure: Tape stripping<br>* Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss<br>|
| Active Comparator: PAR_2/18<br>Application of formulation PAR_2/18 | Other: Application of emulsion<br>* Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks<br>Procedure: Measurement of physiological skin parameters<br>* Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®<br>Procedure: Tape stripping<br>* Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transepidermal water loss | 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 | 6 weeks | 
| Penetrated amount of fluorescein sodium into the skin using tape stripping/fluorescence spectroscopy | 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 | week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Water-in-oil emulsion, Confocal Raman spectroscopy, Skin parameters, Tape stripping