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

• Status: Completed
• Trial end date: 2017-07-06
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LEO Pharma

Criteria

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.