NCT03192280

Brief Summary

This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
Last Updated

February 24, 2025

Status Verified

July 1, 2017

Enrollment Period

17 days

First QC Date

June 16, 2017

Last Update Submit

February 21, 2025

Conditions

Skin Inflammation

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1 to Day 3

Study Arms (1)

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.

Drug: Leukotriene B4Device: FLIR OneDevice: SCIODevice: MS Band 2Device: AGE readerDevice: HSI prototype (PARC) hyper-spectral cameraDevice: iPhone 7

Interventions

Leukotriene B4DRUG

Leukotriene B4 (LTB4)

All study participants
FLIR OneDEVICE

Thermal imaging attachment to iPhone

All study participants
SCIODEVICE

Handheld near-IR molecular spectroscopy device

All study participants
MS Band 2DEVICE

Wearable "watch-like" device with multiple sensors

All study participants
AGE readerDEVICE

Portable bench top device for in-clinic near UV assessment

All study participants
HSI prototype (PARC) hyper-spectral cameraDEVICE

Portable bench top device for in-clinic multispectral imaging

All study participants
iPhone 7DEVICE

Smart phone

All study participants

Eligibility Criteria

Age25 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

Herston, QLD 4006, Australia

Location

MeSH Terms

Conditions

Dermatitis

Interventions

Leukotriene B4

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LeukotrienesArachidonic AcidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, EssentialAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Paul Griffin, MD

    Q-Pharm Pty Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 20, 2017

Study Start

June 19, 2017

Primary Completion

July 6, 2017

Study Completion

July 6, 2017

Last Updated

February 24, 2025

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)