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

Skin Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192280
• Other study ID #: LHUB-001
• Status: Completed
• Phase: N/A
• First received: June 16, 2017
• Last updated: July 10, 2017
• Start date: June 19, 2017
• Est. completion date: July 6, 2017

Study information

• Verified date: July 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 6, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 40 Years

Eligibility

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).

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.

Related Conditions & MeSH terms

• Dermatitis
• Inflammation
• Skin Inflammation

Intervention

Drug:
• Leukotriene B4
Leukotriene B4 (LTB4)

Device:
• FLIR One
Thermal imaging attachment to iPhone
• SCIO
Handheld near-IR molecular spectroscopy device
• MS Band 2
Wearable "watch-like" device with multiple sensors
• AGE reader
Portable bench top device for in-clinic near UV assessment
• HSI prototype (PARC) hyper-spectral camera
Portable bench top device for in-clinic multispectral imaging
• iPhone 7
Smart phone

Locations

Country	Name	City	State
Australia	Investigational Site	Herston

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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