Topical Application of Highly Concentrated Water-in-oil Emulsions

Not Applicable

Completed

• Conditions: Skin Physiology; Dermal Administration; Emulsions
• Interventions: Other: Application of emulsion; Procedure: Measurement of physiological skin parameters; Procedure: Tape stripping

• Registration Number: NCT03876639
• Lead Sponsor: University of Vienna

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.

Study Timeline

• Study Start: 2019-01-16
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Provision of subject informed consent
• Female or male aged between 18 and 65 years

Exclusion Criteria

• Pregnancy
• Chronic skin conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPM_2/18	Tape stripping	Application of formulation IPM_2/18
PAR_2/18	Measurement of physiological skin parameters	Application of formulation PAR_2/18
IPM_2/18	Application of emulsion	Application of formulation IPM_2/18
IPM_2/18	Measurement of physiological skin parameters	Application of formulation IPM_2/18
PAR_2/18	Tape stripping	Application of formulation PAR_2/18
PAR_2/18	Application of emulsion	Application of formulation PAR_2/18

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Vienna; 🇦🇹 Vienna, Austria