Skin Inflammation
Conditions
Brief summary
This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.
Interventions
DRUGLeukotriene B4
Leukotriene B4 (LTB4)
DEVICEFLIR One
Thermal imaging attachment to iPhone
DEVICESCIO
Handheld near-IR molecular spectroscopy device
DEVICEMS Band 2
Wearable watch-like device with multiple sensors
DEVICEAGE reader
Portable bench top device for in-clinic near UV assessment
DEVICEHSI prototype (PARC) hyper-spectral camera
Portable bench top device for in-clinic multispectral imaging
DEVICEiPhone 7
Smart phone
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC | Day 1 to Day 3 | Spectra from 400 - 1000 nm in 5 nm increments |
Countries
Australia
Outcome results
None listed