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Clinical Trials/NCT04472546
NCT04472546
Completed
Not Applicable

Using the SpiderMass(TM) for in Vivo and Real Time Mass Spectrometry Analysis of Subject's Epidermis Suffering From Chronic Inflammatory Dermatosis Compared to Control Groups

Pierre Fabre Dermo Cosmetique1 site in 1 country210 target enrollmentDecember 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acne
Sponsor
Pierre Fabre Dermo Cosmetique
Enrollment
210
Locations
1
Primary Endpoint
Signals and molecular profiles (including lipid) of the epidermis
Status
Completed
Last Updated
last year

Overview

Brief Summary

The physiological states of the skin are characterized by a certain homeostasis linked to the balance of the metabolic pathways. When these pathways are deregulated, the proteic, lipidic and metabolic is affected. It is thus possible to follow a change in the state of the skin by looking at change in the associated molecular profile.

The PRISM laboratory (INSERM U1192) in Lille has developed an innovative system laser called SpiderMass composed of 4 parts:

  1. A laser used for the micro-sampling of material in vivo,
  2. A transport transfer line of the ablated particles,
  3. A mass spectrometer that analyzes them in real time and generates the molecular profiles of the epidermis,
  4. A data analysis procedure.

The SpiderMass(TM) is of great interest for the study of the skin because it allows non-invasive vivo characterization, and therefore without biopsy or sample preparation. In addition, it will complement techniques already used in the research center such as FTIR spectroscopy. Indeed, in acne studies the FTIR allows to obtain only the Fatty Acid Triglycerid ratio while the SpiderMass permits to detail these lipid classes by each observed molecule on the surface of the skin and follow their evolution.

Registry
clinicaltrials.gov
Start Date
December 13, 2019
End Date
February 2, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pierre Fabre Dermo Cosmetique
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Signals and molecular profiles (including lipid) of the epidermis

Time Frame: baseline

Defined by characteristic peak mass intensities - SpiderMass

Cutaneous hydratation for atopic dermatitis subgroup and its associated control

Time Frame: baseline

By hydratation index - Corneometer

Global lipid quantity measured on face acnea, scalp seborrheic dermatitis, face rosacea (papulotelangiectasic stage of erythrocouperosis) and corresponding control volunteers

Time Frame: baseline

Global sebum level measurement expressed in arbitrary index with a Sebumeter SM815 system (Courage+Khazaka electronic GmbH, Köln. Germany)

Molecular profiles (including lipid) of the epidermis according to sampling method and the measurements of the signals obtained method

Time Frame: baseline

* sampling method - absorbant paper, in vivo and / or by scotch * measurements of the signals obtained -in vivo or FTIR

State of the cutaneous barrier for atopic dermatitis and corresponding control volunteers

Time Frame: baseline

Rate of the Trans Epithelial Water Loss (TEWL) by arbitrary units with an Aquaflux system (Biox Systems Ltd, London. UK)

Impact of several factors (dermatosis, area, gender, age) on the molecular profiles of the epidermis

Time Frame: baseline

Characteristic peak mass intensities - SpiderMass

Skin state evaluation on the lesional and perilesional areas

Time Frame: baseline

Illustrative descriptions of the skin state with photographs, taken by an iPhone 6S (Apple, Cupertino. Califronia, USA) dedicated to the study

Study Sites (1)

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