Skin InflammationNCT03192280
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
A study testing Leukotriene B4, FLIR One and SCIO in people with Skin Inflammation, run by LEO Pharma at 1 site in Australia.
Trial summary
This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation. Read more about this study
- Who is it for?
- Ages 25 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Inflammation
- What is being tested?
- Leukotriene B4, FLIR One and SCIO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Jun 2017to 6 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.
- Conditions
- Skin Inflammation
- Being tested
- Leukotriene B4, FLIR One, SCIO, MS Band 2, AGE reader
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukotriene B4Drug
Leukotriene B4 (LTB4)
FLIR OneDevice
Thermal imaging attachment to iPhone
SCIODevice
Handheld near-IR molecular spectroscopy device
MS Band 2Device
Wearable "watch-like" device with multiple sensors
AGE readerDevice
Portable bench top device for in-clinic near UV assessment
HSI prototype (PARC) hyper-spectral cameraDevice
Portable bench top device for in-clinic multispectral imaging
iPhone 7Device
Smart phone
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start19 Jun 2017
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Griffin, MD, Principal investigator, Q-Pharm Pty Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192280
- Sponsor's protocol ID
- LHUB-001
- Status last verified
- Jul 2017
- First submitted
- 16 Jun 2017
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03192280
- Acronym / sponsor ID
- LHUB-001
- Conditions
- Skin Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Drug: Leukotriene B4, Device: FLIR One, Device: SCIO, Device: MS Band 2, Device: AGE reader, Device: HSI prototype (PARC) hyper-spectral camera, Device: iPhone 7Each 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukotriene B4Leukotriene B4 (LTB4) | Drug | All study participants |
| FLIR OneThermal imaging attachment to iPhone | Device | All study participants |
| SCIOHandheld near-IR molecular spectroscopy device | Device | All study participants |
| MS Band 2Wearable "watch-like" device with multiple sensors | Device | All study participants |
| AGE readerPortable bench top device for in-clinic near UV assessment | Device | All study participants |
| HSI prototype (PARC) hyper-spectral cameraPortable bench top device for in-clinic multispectral imaging | Device | All study participants |
| iPhone 7Smart phone | Device | All study participants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Skin Inflammation
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Griffin, MD principal investigator
Q-Pharm Pty Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukotriene B4, FLIR One and SCIO in people with Skin Inflammation, run by LEO Pharma at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC (time frame: Day 1 to Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.