Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

Primary outcome [1] 0 0
Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC - Spectra from 400 - 1000 nm in 5 nm increments
Timepoint [1] 0 0
Day 1 to Day 3

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
Can healthy volunteers participate?
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
Allocation to intervention
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
LEO Pharma

Ethics approval
Ethics application status

Brief summary
This trial will test the feasibility of various imaging devices to detect local skin
inflammation prior to clinical manifestation.
Trial website
Trial related presentations / publications
Public notes

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
Other publications