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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

Primary Purpose

Skin Inflammation

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Leukotriene B4

FLIR One

SCIO

MS Band 2

AGE reader

HSI prototype (PARC) hyper-spectral camera

iPhone 7

About this trial

This is an interventional diagnostic trial for Skin Inflammation

Eligibility Criteria

25 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All study participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03192280

First Posted

June 16, 2017

Last Updated

July 10, 2017

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03192280

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

June 19, 2017 (Actual)

Primary Completion Date

July 6, 2017 (Actual)

Study Completion Date

July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Inflammation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All study participants

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

Leukotriene B4

Intervention Description

Leukotriene B4 (LTB4)

Intervention Type

Device

Intervention Name(s)

FLIR One

Intervention Description

Thermal imaging attachment to iPhone

Intervention Type

Device

Intervention Name(s)

SCIO

Intervention Description

Handheld near-IR molecular spectroscopy device

Intervention Type

Device

Intervention Name(s)

MS Band 2

Intervention Description

Wearable "watch-like" device with multiple sensors

Intervention Type

Device

Intervention Name(s)

AGE reader

Intervention Description

Portable bench top device for in-clinic near UV assessment

Intervention Type

Device

Intervention Name(s)

HSI prototype (PARC) hyper-spectral camera

Intervention Description

Portable bench top device for in-clinic multispectral imaging

Intervention Type

Device

Intervention Name(s)

iPhone 7

Intervention Description

Smart phone

Primary Outcome Measure Information:

Title

Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC

Description

Spectra from 400 - 1000 nm in 5 nm increments

Time Frame

Day 1 to Day 3

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Griffin, MD

Organizational Affiliation

Q-Pharm Pty Limited

Official's Role

Principal Investigator

Facility Information:

Facility Name

Investigational Site

City

Herston

ZIP/Postal Code

QLD 4006

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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