NCT02854475

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

July 27, 2016

Last Update Submit

July 29, 2016

Conditions

Dermatologic DisordersDisorder of Cholesterol Metabolism

Keywords

skin parameterscholesterolRaman spectroscopy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Study Arms (1)

Proband group

EXPERIMENTAL

Raman spectroscopy and venous blood collection

Procedure: Venous blood collectionProcedure: Raman spectroscopy

Interventions

Venous blood collectionPROCEDURE

weekly within two weeks

Proband group
Raman spectroscopyPROCEDURE

weekly within two weeks, on the volar forearm, using a RiverDiagnostics gen2-SCA Skin Composition Analyzer

Proband group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Chronic skin conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin Diseases

Interventions

Spectrum Analysis, Raman

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Scattering, RadiationChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mag. pharm.

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 3, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-07