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

Not Applicable

Completed

• Conditions: Skin Inflammation
• Interventions: 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

• Registration Number: NCT03192280
• Lead Sponsor: LEO Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-16
• Study Start: 2017-06-19
• Study First Posted: 2017-06-20
• Status Verified: 2017-07
• Primary Completion: 2017-07-06
• Study Completion: 2017-07-06
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All study participants	HSI prototype (PARC) hyper-spectral camera	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.
All study participants	FLIR One	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.
All study participants	MS Band 2	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.
All study participants	SCIO	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.
All study participants	iPhone 7	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.
All study participants	AGE reader	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.
All study participants	Leukotriene B4	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational Site; 🇦🇺 Herston, Australia