Skin IaM: An Exploratory Clinical Trial to Evaluate Changes in Skin Appearance, Colour, and/or Texture Following the Induction of a Local Inflammatory Skin Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC
研究概览
简要总结
This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged >25- <40 years.
- •Healthy, non-smoker.
- •In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits.
- •Subject is capable of understanding and signing an informed consent form.
- •White origin (limit Skin Fitzpatrick I to III).
排除标准
- •Male aged < 25 years or >40 years.
- •Female of any age.
- •Tattoos on or within 5 cm of the area to be assessed.
- •Scars on or with 5 cm of the area to be assessed.
- •Current, active inflammatory skin disease, or past history of any inflammatory skin disease (other than acne) such as psoriasis, atopic dermatitis.
- •Suffered from any significant allergies (i.e. food, environmental, contact).
- •Subjects who are immunocompromised (i.e. HIV positive, Hepatitis C, transplant, etc.), based on clinical history.
- •Subjects who currently have an activated immune system (e.g from current infection or recent vaccination).
- •Subjects who have a history of chronic disease such as diabetes.
- •Use of investigational therapy in the preceding month prior to screening visit.
- •Use of G-CSF, GM-CSF, IL-2, IFNs, erythropoietin, systemic or inhaled steroids within one month of the screening visit.
- •Use of oral analgesics/anti-inflammatories (e.g. paracetamol, ibuprofen, aspirin, codeine) or topical anti-inflammatories (e.g., ibuprofen) within 5 days of the screening visit.
- •Concurrent disease or conditions that may present a risk to the subjects.
研究组 & 干预措施
All study participants
Each subject will receive single topical induction application of Leukotriene B4 (LTB4) on the inner arm.
Images of the treated area will be captured using multiple medical devices.
干预措施: Leukotriene B4 (Drug)
All study participants
Each subject will receive single topical induction application of Leukotriene B4 (LTB4) on the inner arm.
Images of the treated area will be captured using multiple medical devices.
干预措施: FLIR One (Device)
All study participants
Each subject will receive single topical induction application of Leukotriene B4 (LTB4) on the inner arm.
Images of the treated area will be captured using multiple medical devices.
干预措施: SCIO (Device)
All study participants
Each subject will receive single topical induction application of Leukotriene B4 (LTB4) on the inner arm.
Images of the treated area will be captured using multiple medical devices.
干预措施: MS Band 2 (Device)
All study participants
Each subject will receive single topical induction application of Leukotriene B4 (LTB4) on the inner arm.
Images of the treated area will be captured using multiple medical devices.
干预措施: AGE reader (Device)
All study participants
Each subject will receive single topical induction application of Leukotriene B4 (LTB4) on the inner arm.
Images of the treated area will be captured using multiple medical devices.
干预措施: HSI prototype (PARC) hyper-spectral camera (Device)
All study participants
Each subject will receive single topical induction application of Leukotriene B4 (LTB4) on the inner arm.
Images of the treated area will be captured using multiple medical devices.
干预措施: iPhone 7 (Device)
结局指标
主要结局
Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC
时间窗: Day 1 to Day 3
Spectra from 400 - 1000 nm in 5 nm increments
次要结局
未报告次要终点