Clinical trial: Indigo Naturalis in Treating Atopic Dermatitis Topically (NCT02669888)

Eligibility criteria:
Inclusion Criteria:

          1. Between 6 and 65 years old, female or male.

          2. Atopic dermatitis fulfilling the diagnostic criteria of Williams et al.

          3. Atopic dermatitis involving <40% of BSA. (Base on the BSA result of Screening)

          4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to
             mild, moderate or severe disease. (Base on the IGA result of Screening)

          5. Female patients of child-bearing age with negative pregnancy test at screening.

          6. Female patients of child-bearing age that agree to continue using birth control
             measures approved by the investigator and agree not to lactate for the duration of the
             study.

          7. Agree to only receive stable doses of an additive-free, basic bland emollient for at
             least 7 days before baseline (day0)

          8. Willing to comply with study protocol and agree to sign an informed consent form.

        Exclusion Criteria:

          1. Having a history of topical or systematical hypersensitivity to indigo naturalis or
             its excipient (e.g. beeswax) in ointment

          2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive
             agents) within 30 days.

          3. Having used topical therapy (e.g. topical corticosteroids) for dermatitis within 7
             days before the first application of the study medication.

          4. Having a significant concurrent disease, such as: significant abnormalities in
             hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes
             mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.

          5. Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).

          6. Women who are lactating, pregnant or preparing to be pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 65 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