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

Study Overview
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Brief Summary
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This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.

Official Title
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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

Conditions
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Skin Inflammation

Intervention / Treatment
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* Drug: Leukotriene B4
* Device: FLIR One
* Device: SCIO
* Device: MS Band 2
* Device: AGE reader
* Device: HSI prototype (PARC) hyper-spectral camera
* Device: iPhone 7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All study participants<br>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. | Drug: Leukotriene B4<br>* Leukotriene B4 (LTB4)<br>Device: FLIR One<br>* Thermal imaging attachment to iPhone<br>Device: SCIO<br>* Handheld near-IR molecular spectroscopy device<br>Device: MS Band 2<br>* Wearable watch-like device with multiple sensors<br>Device: AGE reader<br>* Portable bench top device for in-clinic near UV assessment<br>Device: HSI prototype (PARC) hyper-spectral camera<br>* Portable bench top device for in-clinic multispectral imaging<br>Device: iPhone 7<br>* Smart phone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC | Spectra from 400 - 1000 nm in 5 nm increments | Day 1 to Day 3 |