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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- LEO Pharma
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC
Study Overview
Brief Summary
This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 40 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: iPhone 7 (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.
Intervention: 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.
Intervention: Leukotriene B4 (Drug)
Outcomes
Primary Outcomes
Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC
Time Frame: Day 1 to Day 3
Spectra from 400 - 1000 nm in 5 nm increments
Secondary Outcomes
No secondary outcomes reported