Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters

Dermatologic Disorders Clinical Trial

Official title:

Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854475
• Other study ID #: Raman 2016.1
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: July 29, 2016
• Start date: July 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to

I. determine several skin parameters, for example natural moisturizing factor (NMF) and cholesterol, with Raman spectroscopy in vivo and

II. compare the results with the corresponding cholesterol levels measured in venous blood.

Description:

In vivo Raman experiments will be carried out weekly on voluntary participants using a RiverDiagnostics gen2-SCA Skin Composition Analyzer (RiverDiagnostics, Rotterdam, Netherlands). All experiments will be carried out on the volar forearm. Semi-quantitative concentration profiles for several skin parameters will be determined, for example natural moisturizing factor (NMF) and cholesterol.

Additionally the total cholesterol level will be detected by venous blood sample analysis. The blood samples will be taken weekly within two weeks, similar to the Raman measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dermatologic Disorders
• Disease
• Disorder of Cholesterol Metabolism
• Skin Diseases

Intervention

Procedure:
• Venous blood collection
weekly within two weeks
• Raman spectroscopy
weekly within two weeks, on the volar forearm, using a RiverDiagnostics gen2-SCA Skin Composition Analyzer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Vienna	Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the fasting total cholesterol levels measured in skin with confocal Raman spectroscopy and in venous blood collected by venipuncture		2 weeks	No
Secondary	Concentration curves of various skin substances, such as NMF, urea and water as evidence for the eligibility of confocal Raman spectroscopy for the in vivo measurement of skin		2 weeks	No