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

NCT04472546 | Completed

• 2 other identifiers: SMPATHO012019-A02105-52
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Conditions

Acne; Atopic Dermatitis; Psoriasis Vulgaris; Rosacea; Seborrheic Dermatitis; Healthy

Keywords

dermatitis; acne of the face; Atopic Dermatitis of the upper limb; Psoriasis Vulgaris; Rosacea; seborrheic dermatitis; SpiderMass; Lipid Index; Laser; Hydratation index; Transepidermal water loss; Scotch sampling; Absorbant paper

Outcome Measures

Primary Outcomes (7)

• Signals and molecular profiles (including lipid) of the epidermis

  Defined by characteristic peak mass intensities - SpiderMass

  baseline

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

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

  baseline

• Cutaneous hydratation for atopic dermatitis subgroup and its associated control

  By hydratation index - Corneometer

  baseline

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

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

  baseline

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

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

  baseline

• Skin state evaluation on the lesional and perilesional areas

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

  baseline

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

  Characteristic peak mass intensities - SpiderMass

  baseline

Study Arms (2)

Control subject group

OTHER

Divided in 5 subgroups : * A': associated to acne of the face subgroup * B' : associated to atopic dermatitis of the upper limb subgroup * C' : associated to vulgar plaque psoriasis subgroup * D' : associated to telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E' : associated to seborrheic dermatitis of scalp subgroup

Other: in-vivo mesure; Other: Scotch; Other: Lipid index; Other: Absorbant paper; Other: Hydratation Index; Other: TransEpidermal Water Loss

Subject group with dermatitis

OTHER

Divided in 5 subgroups : * A : acne of the face subgroup * B : Atopic dermatitis of the upper limb subgroup * C : Vulgar plaque psoriasis subgroup * D : Telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E : Seborrheic dermatitis of scalp subgroup

Other: in-vivo mesure; Other: Scotch; Other: Lipid index; Other: Absorbant paper; Other: Hydratation Index; Other: TransEpidermal Water Loss

Interventions

in-vivo mesure OTHER

* for acne of the face subgroup and its associated control : face and inner side of the forearm * for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm * for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm * for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm

Also known as: SpiderMass mesure

Control subject group; Subject group with dermatitis

Scotch OTHER

* for acne of the face subgroup and its associated control : face and inner side of the forearm * for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm * for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm * for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm

Control subject group; Subject group with dermatitis

Lipid index OTHER

* for acne of the face subgroup and its associated control : face * for seborrheic dermatitis of scalp subgroup and its associated control: scalp * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face

Control subject group; Subject group with dermatitis

Absorbant paper OTHER

* for acne of the face subgroup and its associated control : face * for seborrheic dermatitis of scalp subgroup and its associated control: scalp * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: forehead

Control subject group; Subject group with dermatitis

Hydratation Index OTHER

-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded)

Control subject group; Subject group with dermatitis

TransEpidermal Water Loss OTHER

-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded)

Control subject group; Subject group with dermatitis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• CRITERIA RELATED TO THE POPULATION:
• Male or female subject having signed a written informed consent for his/her participation to the study
• Subject with a phototype II to IV according to the Fitzpatrick scale
• Subject affiliated to a social security system or health insurance, or is a beneficiary
• For acne of the face subgroup and its associated control: Male or female, 18 to 30 years old included
• For atopic dermatitis of the upper limb subgroup and its associated control: Male or female, 20 to 50 years old included
• For vulgar plaque psoriasis subgroup and its associated control: Male or female, 20 to 55 years old included
• For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: Male or female, 30 to 55 years old included
• For seborrheic dermatitis of scalp subgroup and its associated control: Male or female, 20 to 45 years old included
• CRITERIA RELATED TO DERMATOSIS:
• For subjects of the acne of the face subgroup :
• Subjects with mild to severe acne on the face with a GEA (Global Acne Evaluation) score of 2 to 4 on a rating scale ranging from 0 (no injury) to 5 (very severe)
• Subject presenting on the face, at least one zone:
• Lesional in immediate border of a papule
• Peri-lesional near inflammatory lesions (papule, about 1 cm)

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Centre de Recherche sur la Peau

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Acne Vulgaris; Dermatitis, Atopic; Rosacea; Dermatitis, Seborrheic; Dermatitis

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Study Officials

• Thérèse NOCERA, Mrs

  Centre de Recherche sur La Peau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject group : Exploratory study, monocentric and comparative performed at: * control subject group, divided in 5 subgroups : * A': associated to acne of the face subgroup * B' : associated to atopic dermatitis of the upper limb subgroup * C' : associated to vulgar plaque psoriasis subgroup * D' : associated to telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E' : associated to seborrheic dermatitis of scalp subgroup * subject group with dermatitis, divided in 5 subgroups : * A: acne of the face subgroup * B : atopic dermatitis of the upper limb subgroup * C : vulgar plaque psoriasis subgroup * D : telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E : seborrheic dermatitis of scalp subgroup Visit number : It includes 1 unique visit to the Skin Research Center, Toulouse, France. The maximum duration of participation for a subject is 1 day (around 2 hours).

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: July 15, 2020
• Study Start: December 13, 2019
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

FR (1)