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

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

Study Overview

• Status: Completed
• Conditions: Skin Inflammation
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Herston, Australia, QLD 4006
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Leukotriene B4; Leukotriene B4 (LTB4); Device: FLIR One; Thermal imaging attachment to iPhone; Device: SCIO; Handheld near-IR molecular spectroscopy device; Device: MS Band 2; Wearable "watch-like" device with multiple sensors; Device: AGE reader; Portable bench top device for in-clinic near UV assessment; Device: HSI prototype (PARC) hyper-spectral camera; Portable bench top device for in-clinic multispectral imaging; Device: iPhone 7; Smart phone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): July 6, 2017
• Study Completion (Actual): July 6, 2017

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Dermatitis
• Other Study ID Numbers: LHUB-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes