Topical Application of Highly Concentrated Water-in-oil Emulsions
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 16, 2019
CompletedFirst Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2019
CompletedApril 17, 2019
April 1, 2019
2 months
March 11, 2019
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
IPM_2/18
ACTIVE COMPARATORApplication of formulation IPM\_2/18
PAR_2/18
ACTIVE COMPARATORApplication of formulation PAR\_2/18
Interventions
Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks
Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®
Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss
Eligibility Criteria
You may qualify if:
- Provision of subject informed consent
- Female or male aged between 18 and 65 years
You may not qualify if:
- Pregnancy
- Chronic skin conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Viennalead
- Medical University of Viennacollaborator
Study Sites (1)
University of Vienna
Vienna, Austria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 15, 2019
Study Start
January 16, 2019
Primary Completion
March 18, 2019
Study Completion
March 18, 2019
Last Updated
April 17, 2019
Record last verified: 2019-04