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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

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ClinicalTrials.gov Identifier: NCT03192280
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Skin Inflammation 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 19, 2017
Actual Primary Completion Date : July 6, 2017
Actual Study Completion Date : July 6, 2017

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192280


Locations
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Australia
Investigational Site
Herston, Australia, QLD 4006
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Paul Griffin, MD Q-Pharm Pty Limited

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03192280     History of Changes
Other Study ID Numbers: LHUB-001
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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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

Additional relevant MeSH terms:
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Inflammation
Dermatitis
Pathologic Processes
Skin Diseases