Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters

July 29, 2016 updated by: Lisa Binder, University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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

Yes

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Proband group
Raman spectroscopy and venous blood collection
Procedure: Venous blood collection
weekly within two weeks
Procedure: Raman spectroscopy
weekly within two weeks, on the volar forearm, using a RiverDiagnostics gen2-SCA Skin Composition Analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of the fasting total cholesterol levels measured in skin with confocal Raman spectroscopy and in venous blood collected by venipuncture
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Collaborators

Medical University of Vienna

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

July 1, 2016

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Raman 2016.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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