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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

Tracking Information
First Submitted Date  ICMJE June 16, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE June 19, 2017
Actual Primary Completion Date July 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03192280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Skin Inflammation
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2017)
10
Actual Study Completion Date  ICMJE July 6, 2017
Actual Primary Completion Date July 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03192280
Other Study ID Numbers  ICMJE LHUB-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Griffin, MD Q-Pharm Pty Limited
PRS Account LEO Pharma
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP