Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT01063218
Eligibility Criteria:
Inclusion Criteria:
* Male or Female patients
* 2 to 10 years old.
* with light to moderate with no signs of acute/ sub-acute eczema or in activity.
* Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.
* Subjects can present light to moderate dryness.
Exclusion Criteria:
* Subjects presenting any serious systemic disease
* Subjects with medical history regarding serious asthma
* Subjects with known or suspected allergy to one of the investigational products
* Subjects with acute atopic eczema or in activity, needing systemic antibiotics
* Subjects with signs of active infections on skin
* Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF)
* Female subjects who are not in pre-menarche period.
* Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study.
* Patient with a wash-out period for treatment less than:
* injectable corticoids: 60 days
* systemic corticoids: 15 days
* topic corticoids: 8 days
* topic immunomodulator: 8 days
* antihistaminic : 48 hours
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
10 Years
Study:
NCT01063218
Study Brief:
Protocol Section:
NCT01063218