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
NCT ID: NCT03192280
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2017-06-19
2017-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Leukotriene B4
Leukotriene B4 (LTB4)
FLIR One
Thermal imaging attachment to iPhone
SCIO
Handheld near-IR molecular spectroscopy device
MS Band 2
Wearable "watch-like" device with multiple sensors
AGE reader
Portable bench top device for in-clinic near UV assessment
HSI prototype (PARC) hyper-spectral camera
Portable bench top device for in-clinic multispectral imaging
iPhone 7
Smart phone
Interventions
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Leukotriene B4
Leukotriene B4 (LTB4)
FLIR One
Thermal imaging attachment to iPhone
SCIO
Handheld near-IR molecular spectroscopy device
MS Band 2
Wearable "watch-like" device with multiple sensors
AGE reader
Portable bench top device for in-clinic near UV assessment
HSI prototype (PARC) hyper-spectral camera
Portable bench top device for in-clinic multispectral imaging
iPhone 7
Smart phone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
40 Years
MALE
Yes
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Griffin, MD
Role: PRINCIPAL_INVESTIGATOR
Q-Pharm Pty Limited
Locations
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Investigational Site
Herston, , Australia
Countries
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Other Identifiers
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LHUB-001
Identifier Type: -
Identifier Source: org_study_id
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