Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters

NCT02854475 — Not applicable, Completed, 15 participants, University of Vienna

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

Registry	NCT02854475
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none
Enrollment	15 (Actual)
Sponsor	University of Vienna (Other); collaborators: Medical University of Vienna
Conditions	Dermatologic Disorders, Disorder of Cholesterol Metabolism
Interventions	Venous blood collection, Raman spectroscopy (Procedure)
Dates	start 2016-07-01, primary completion 2016-07-01, completion 2016-07-01, first posted 2016-08-03, last updated 2016-08-03

-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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Proband group	Experimental	Procedure: Venous blood collection; Procedure: Raman spectroscopy	Raman spectroscopy and venous blood collection

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

+Outcome measures

Primary outcomes

Correlation of the fasting total cholesterol levels measured in skin with confocal Raman spectroscopy and in venous blood collected by venipuncture [2 weeks]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Provision of subject informed consent
* Female or male aged between 18 and 65 years

Exclusion Criteria:

* Pregnancy
* Chronic skin conditions