Skin IaM: An Exploratory Clinical Trial to Evaluate Changes in Skin Appearance, Colour, and/or Te… (NCT03192280) | Clinical Trial Compass
CompletedNot Applicable
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
Australia12 participantsStarted 2017-06-19
Plain-language summary
This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.
Who can participate
Age range25 Years – 40 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Time-point of change from baseline and comparator in electro-magnetic spectra as measured by HSI PARC