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

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.