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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

LEO Pharma logo

LEO Pharma

Status

Completed

Conditions

Skin Inflammation

Treatments

Device: AGE reader
Device: SCIO
Device: HSI prototype (PARC) hyper-spectral camera
Device: iPhone 7
Drug: Leukotriene B4
Device: MS Band 2
Device: FLIR One

Study type

Interventional

Funder types

Industry

Identifiers

NCT03192280
LHUB-001

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

Male

Ages

25 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

All study participants
Experimental group
Description:
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:
Device: MS Band 2
Device: FLIR One
Drug: Leukotriene B4
Device: iPhone 7
Device: HSI prototype (PARC) hyper-spectral camera
Device: AGE reader
Device: SCIO

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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