Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03192280




Registration number
NCT03192280
Ethics application status
Date submitted
16/06/2017
Date registered
20/06/2017
Date last updated
11/07/2017

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
LHUB-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Inflammation 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Leukotriene B4
Treatment: Devices - FLIR One
Treatment: Devices - SCIO
Treatment: Devices - MS Band 2
Treatment: Devices - AGE reader
Treatment: Devices - HSI prototype (PARC) hyper-spectral camera
Treatment: Devices - iPhone 7

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.


Treatment: Drugs: Leukotriene B4
Leukotriene B4 (LTB4)

Treatment: Devices: FLIR One
Thermal imaging attachment to iPhone

Treatment: Devices: SCIO
Handheld near-IR molecular spectroscopy device

Treatment: Devices: MS Band 2
Wearable "watch-like" device with multiple sensors

Treatment: Devices: AGE reader
Portable bench top device for in-clinic near UV assessment

Treatment: Devices: HSI prototype (PARC) hyper-spectral camera
Portable bench top device for in-clinic multispectral imaging

Treatment: Devices: iPhone 7
Smart phone
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC
Timepoint [1] 0 0
Day 1 to Day 3

Eligibility
Key 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).
Minimum age
25 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/07/2017
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site - Herston
Recruitment postcode(s) [1] 0 0
QLD 4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LEO Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Griffin, MD
Address 0 0
Q-Pharm Pty Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03192280