Use of the SpiderMass for in Vivo Analysis of the Skin in Five Chronic Inflammatory Dermatosis

Not Applicable

Completed

• Conditions: Healthy; Psoriasis Vulgaris; Rosacea; Seborrheic Dermatitis; Acne; Atopic Dermatitis

• Registration Number: NCT04472546
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-13
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-15
• Primary Completion: 2023-02-02
• Study Completion: 2024-02-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Signals and molecular profiles (including lipid) of the epidermis	baseline	Defined by characteristic peak mass intensities - SpiderMass
Cutaneous hydratation for atopic dermatitis subgroup and its associated control	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	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	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	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	baseline	Characteristic peak mass intensities - SpiderMass
Skin state evaluation on the lesional and perilesional areas	baseline	Illustrative descriptions of the skin state with photographs, taken by an iPhone 6S (Apple, Cupertino. Califronia, USA) dedicated to the study

Trial Locations

Locations (1)

Centre de Recherche sur la Peau; 🇫🇷 Toulouse, France