Topical Application of Highly Concentrated Water-in-oil Emulsions

Skin Physiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876639
• Other study ID #: SkinStudy 2019.1
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: March 18, 2019

Study information

• Verified date: April 2019
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Provision of subject informed consent

• Female or male aged between 18 and 65 years

Exclusion Criteria:

• Pregnancy

• Chronic skin conditions

Related Conditions & MeSH terms

• Dermal Administration
• Emulsions
• Skin Physiology

Intervention

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

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
University of Vienna	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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