Skin PhysiologyNCT03876639
Topical Application of Highly Concentrated Water-in-oil Emulsions
A study testing Application of emulsion, Measurement of physiological skin parameters and Tape stripping in people with Skin Physiology and Dermal Administration, run by University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Physiology, Dermal Administration, Emulsions
- What is being tested?
- Application of emulsion, Measurement of physiological skin parameters and Tape stripping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 16 Jan 2019to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of subject informed consent
- Female or male aged between 18 and 65 years
Who cannot join
- Pregnancy
- Chronic skin conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Physiology, Dermal Administration, Emulsions
- Being tested
- Application of emulsion, Measurement of physiological skin parameters, Tape stripping
- Keywords
- Water-in-oil emulsion, Confocal Raman spectroscopy, Skin parameters, Tape stripping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of emulsionOther
Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks
Measurement of physiological skin parametersProcedure or surgery
Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®
Tape strippingProcedure or surgery
Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss
| Study group | Role | What they receive |
|---|---|---|
| IPM_2/18 | Active comparator | Application of formulation IPM_2/18 Receives: Other: Application of emulsion; Procedure: Measurement of physiological skin parameters; Procedure: Tape stripping |
| PAR_2/18 | Active comparator | Application of formulation PAR_2/18 Receives: Other: Application of emulsion; Procedure: Measurement of physiological skin parameters; Procedure: Tape stripping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start16 Jan 2019
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Lisa Binder, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876639
- Sponsor's protocol ID
- SkinStudy 2019.1
- Status last verified
- Apr 2019
- First submitted
- 11 Mar 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Highly Concentrated Water-in-oil Emulsions: Physiological Skin Parameters and Skin Penetration in Vivo - A Pilot Study
- ClinicalTrials.gov ID
- NCT03876639
- Acronym / sponsor ID
- SkinStudy 2019.1
- Conditions
- Skin Physiology, Dermal Administration, Emulsions
- Keywords
- Water-in-oil emulsion, Confocal Raman spectroscopy, Skin parameters, Tape stripping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPM_2/18 | Active comparator | Other: Application of emulsion, Procedure: Measurement of physiological skin parameters, Procedure: Tape strippingApplication of formulation IPM_2/18 |
| PAR_2/18 | Active comparator | Other: Application of emulsion, Procedure: Measurement of physiological skin parameters, Procedure: Tape strippingApplication of formulation PAR_2/18 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provision of subject informed consent
- Female or male aged between 18 and 65 years
Key exclusion criteria (2 listed)
- Pregnancy
- Chronic skin conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of emulsionDaily application of the assigned formulation on the non-dominant volar forearm for 4 weeks | Other | IPM_2/18, PAR_2/18 |
| Measurement of physiological skin parametersWeekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon® | Procedure or surgery | IPM_2/18, PAR_2/18 |
| Tape strippingRemoval of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss | Procedure or surgery | IPM_2/18, PAR_2/18 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of emulsion, Measurement of physiological skin parameters and Tape stripping in people with Skin Physiology and Dermal Administration, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transepidermal water loss (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.