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Completed

NCT Number: NCT03876639

Topical Application of Highly Concentrated Water-in-oil Emulsions

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.

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Key information

Conditions

Skin Physiology Dermal Administration Emulsions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vienna

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Chronic skin conditions

Treatment and study plan

Application of emulsion

Other

Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks

Measurement of physiological skin parameters

Procedure

Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®

Tape Stripping

Procedure

Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss

Primary outcomes

  1. Change in transepidermal water loss

    Time frame: 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

  2. Penetrated amount of fluorescein sodium into the skin using tape stripping/fluorescence spectroscopy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Collaborators

  • Medical University of Vienna

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2019
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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