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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Signals and molecular profiles (including lipid) of the epidermis
研究概览
简要总结
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:
- A laser used for the micro-sampling of material in vivo,
- A transport transfer line of the ablated particles,
- A mass spectrometer that analyzes them in real time and generates the molecular profiles of the epidermis,
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 woman of childbearing potential use of an effective method of contraception, as assessed by the investigator for at least 4 weeks before inclusion in the study
- •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)
- •Subject presenting on the inner side of the forearm a reference zone without lesion
- •For subjects in the atopic dermatitis subgroup of upper limbs:
- •Subject with atopic dermatitis on the upper limbs, mild to moderate with SCORAD (SCORing Atopic Dermatitis) between 15 and 40 included with:
- •A dryness score ≥ 2 on a scale ranging from 0 (absent) to 3 (severe)
- •Subject having at least one inflammatory flare of atopic dermatitis on the upper limbs in the 2 years before the day of inclusion
- •Subject presenting on the upper limb (hand excluded) at least one zone:
- •Lesional defined by the signs of target SCORAD between 3 and 12:
- •Erythema from 1 to 3
- •Dryness ≥2
- •Oedema / papule from 0 to 3
- •Lesions oozing or crusting 0
- •Excoriation of 0
- •Lichenification from 0 to 3 On a scale ranging from 0 (absent) to 3 (severe)
- •Peri-lesional near the lesion zone (about 1cm)
- •Subject presenting on the inner side of the forearm a reference zone without lesion
- •For vulgar plaque psoriasis subgroup
- •Subject with mild to moderate erythematous-squamous plaque psoriasis whose IGA (Investigator Global Assessment) score is between 2 and 3, on a rating scale ranging from 0 (clear) to 5 (very severe)
- •Subject with on the upper limb (hand excluded) or lower limb at least one zone:
- •Lesional:
- •Without fissure and without crust
- •With erythema score ≥ 1 on a scale ranging from 0 (absent) to 3 (severe)
- •With desquamation score between 1 (mild) and 2 (moderate) on a scale ranging from 0 (absent) to 3 (severe)
- •With an oedema score of 0 (absent) on a scale ranging from 0 (absent) to 3 (severe)
- •Peri-lesional:
- •Without fissure and without crust
- •Near the lesion zone (about 1 cm)
- •Subject presenting on the inner side of the forearm a reference zone without lesion
- •For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup
- •- Subject with telangiectasic erythrocouperosis and papule of the face mild to moderate with an IGA score between 2 and 3 on a rating scale ranging from 0 (absent) to 4 (severe)
- •Subject presenting on the face at least one zone:
- •Lesional: immediate border of the papule with a persistent erythema score ≥ 1 on a rating scale ranging from 0 (absent) to 3 (severe)
- •Peri-lesional:
- •Near inflammatory lesions (papule, about 1 cm)
- •Ranging of at least 1 point less in the erythema score compared to the lesion zone
- 另有 54 项未显示
排除标准
- 未提供
结局指标
主要结局
Signals and molecular profiles (including lipid) of the epidermis
时间窗: baseline
Defined by characteristic peak mass intensities - SpiderMass
Cutaneous hydratation for atopic dermatitis subgroup and its associated control
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline
Characteristic peak mass intensities - SpiderMass
Skin state evaluation on the lesional and perilesional areas
时间窗: baseline
Illustrative descriptions of the skin state with photographs, taken by an iPhone 6S (Apple, Cupertino. Califronia, USA) dedicated to the study
次要结局
未报告次要终点