Clinical trial: Skin Pathology Assessment With Optical Technologies (NCT04295824)

Eligibility criteria:
Inclusion Criteria:

        Healthy subjects and AD patients

          1. Male or female

          2. Aged between 11-60 years

          3. Volunteer understands the purpose, modalities and potential risk of the trial

          4. Volunteers able to read and understand English

          5. Volunteers willing to sign the informed consent

        AD patients:

          1. Volunteers with AD defined according to the UK working party diagnostic criteria

          2. Must have an AD lesion present at either the right or left forearm (Proximal end).

          3. For 10 participants in each AD group: visible AD lesion present on either the right or
             left cheek.

          4. For 10 participants in each AD group: Global severity score (EASI) that matches their
             cohort allocation (Mild/Moderate/Severe).

        According to the UK working party diagnostic criteria, eczema is defined as exhibiting an
        itchy skin condition plus 3 or more of:

          -  History of involvement of the skin creases

          -  Personal history of asthma or hay fever

          -  History of generally dry skin in past year

          -  Visible flexural dermatitis

          -  Onset below age 2

        Instructions to participants 1. Do not ingest caffeine (e.g Coffee) or take
        anti-inflammatory drugs (e.g Ibuprofen) on the imaging day (until after imaging).

        Exclusion Criteria:

          1. Treatment with the following medications within 4 weeks: systemic
             immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine,
             azathioprine, mycophenolate-mofetil, Janus kinase inhibitors, etc.), systemic
             corticosteroids.

          2. Three or more bleach baths during any week within 4 weeks.

          3. Treatment with biologics within 5 half-lives (if known) or 12 weeks.

          4. Treatment with the following medications within 2 weeks if mild/moderate global
             severity or 1 week if severe global severity: topical corticosteroids, topical
             calcineurin inhibitors.

          5. Treatment with any topical leave-on product on the test areas 7 days prior to
             participation if healthy/mild and 24 hours prior to participation if moderate/severe
             global severity.

          6. Volunteers with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense
             body hair that obstruct the test areas.

          7. Volunteers with a condition that in the opinion of the investigator contradicts
             participation in the study.

          8. Volunteer is incapable of giving fully informed consent.

          9. Volunteers judged by the PI to be inappropriate for the trial.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 11 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago.  A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy.  The patient has had a few upper respiratory infections but no major illnesses.  Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance.  Vital signs and milestone examination are within normal limits.  Similar findings are observed on the cheeks and proximal upper extremities.  The diaper area is clear, and no mucosal lesions are present.

Patient description (patient's own words): I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions.

Does the patient match the trial criteria? Contradiction