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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
N/A
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
Not Applicable
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
This trial will test the feasibility of various imaging devices to detect local skin
inflammation prior to clinical manifestation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03192280
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03192280