Clinical trial: A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin (NCT02120833)

Eligibility criteria:
Inclusion Criteria

          1. Able to comprehend and follow the requirements of the study (including availability on
             scheduled visit dates) based upon research site personnel's assessment;

          2. Caregiver is able and willing to provide written informed consent for the participant
             to participate in the trial;

          3. Male or female of any race or ethnicity, 2 months to 35 months of age;

          4. Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by
             Hanifin and Rajka

          5. Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per
             Rajka-Langeland severity index

          6. Willing to stop all emollients, moisturizers and/or other skin barrier cream or
             emulsion treatments for the AD condition during the test period. If using
             corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be
             on a stable dose for a minimum of 1 month;

          7. Willing to undergo a washout period of 2 days before the trial initiation where no use
             of moisturizers or emollients will be allowed; and

          8. Willing and able to comply with scheduled visits, treatment plan, and other trial
             procedures.

        Exclusion Criteria:

          1. Known sensitivity to any investigational product ingredient;

          2. Use of a therapeutic (over the counter or prescription) body wash that contains an
             active ingredient for eczema;

          3. Participation in any clinical study within 30 days of Visit 1;

          4. Relative, partner or staff of any clinical research site personnel;

          5. Active infection of any type at the start of the study;

          6. Severe AD as determined by the Rajka-Langeland Severity Index

          7. AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical
             corticosteroids. If a participant requires any of these medications as rescue therapy
             during the study, the participant will be discontinued from the trial;

          8. Requires any inhaled or intranasal corticosteroids;

          9. Other medical condition that may increase the risk associated with study participation
             or investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the participant
             inappropriate for entry into this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Months old.
Subject must be at most 35 Months

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