Topical Application of Highly Concentrated Water-in-oil Emulsions
April 16, 2019 updated by: Lisa Binder, University of Vienna
Topical Application of Highly Concentrated Water-in-oil Emulsions: Physiological Skin Parameters and Skin Penetration in Vivo - A Pilot Study
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria
- University of Vienna
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of subject informed consent
- Female or male aged between 18 and 65 years
Exclusion Criteria:
- Pregnancy
- Chronic skin conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: IPM_2/18
Application of formulation IPM_2/18
|
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
|
|
Active Comparator: PAR_2/18
Application of formulation PAR_2/18
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 weeks
|
|
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
|
week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2019
Primary Completion (Actual)
March 18, 2019
Study Completion (Actual)
March 18, 2019
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 15, 2019
Study Record Updates
Last Update Posted (Actual)
April 17, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- SkinStudy 2019.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.