Clinical trial: A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis (NCT02094235)

Eligibility criteria:
Inclusion Criteria

          1. Pediatric out-patients diagnosed with AD aged 2 to 15 years at the time of written
             informed consent. Diagnosis for AD should be made in accordance with the "Guidelines
             for Management of Atopic Dermatitis" by the Japanese Dermatological Association.

          2. Mild to moderate clinical symptoms appearing at baseline in areas where the
             application of study drug is possible, except the skin of face/head and non-dermal
             areas such as mucosa

          3. Evaluable skin lesions appearing at baseline. "Evaluable skin lesion" means rash area
             of 25 to 100 cm2 in the trunk or extremities, in which at least one of dermal symptoms
             (erythema, exudate/eschar, excoriation or lichenification) must be moderate in
             severity.

          4. Continuous use of an appropriate moisturizer for at least 14 days before baseline

          5. Females of child-bearing potential must be negative for pregnancy test at baseline and
             are able to practice effective contraception during the study period including the
             follow-up period

          6. Virile males and females of childbearing potential, who and whose partners consented
             to practice contraception throughout the study period after receiving an explanation
             using the informed consent form and the separately-prepared assent form

          7. Patients whose legally acceptable representatives (caregivers) are able to consent in
             writing to participate in the study and who are able to adhere to the protocol
             requirements. For patients aged 12 years or older at the time of informed consent,
             written consent should be obtained from the patients as well as their legally
             acceptable representatives (caregivers). Also for patients aged below 12 years,
             written informed consent should be obtained whenever possible.

        Exclusion Criteria

          1. Use of biological products which may affect the pathological evaluation of AD within 6
             months before the start of study treatment

          2. Concurrent or recent use of certain topical or systemic medications or phototherapy
             without a sufficient washout period, except hydrocortisone butyrate preparations used
             in areas which are unsuitable for application of study drug at the discretion of the
             investigator

          3. Currently has Kaposi's varicelliform eruption, scabies, molluscum contagiosum,
             impetigo contagious, psoriasis, connective tissue disorder, or Netherton's syndrome,
             etc, which may affect the pathological evaluation of AD

          4. Any past history or present illness of serious allergy such as anaphylactic shock,
             anaphylactic reaction and anaphylactoid reaction, or any past history or present
             illness of drug allergic reaction or hypersensitivity

          5. Has active infection that requires oral or intravenous administration of antibiotics,
             antifungal or antivirus agents at baseline

          6. Currently has an advanced disease or highly abnormal laboratory test result that may
             affect the safety of subject or the implementation of the study

          7. Difficulty in venous access for blood collection

          8. Any past history or present illness of malignant tumor, lymphoma, leukemia or
             lymphoproliferative disorder, except non-melanoma skin carcinoma (e.g., squamous cell
             carcinoma and basal cell carcinoma) which was completely removed and has not recurred
             or metastasized for at least 5 years

          9. Scheduled for surgery during the study

         10. Concurrently enrolled in another clinical study or used any investigational drug or
             device within 30 days before the date of informed consent

         11. Ineligible for participating in the study for other reasons, in the judgment of the
             investigator or subinvestigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 15 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? Entailment