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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01638234
Eligibility Criteria:
Inclusion Criteria:
* Children between 1 and 18 years of age with mild to moderate AD, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months
Exclusion Criteria:
1. Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
2. Those who had received therapy for insomnia within 4 weeks before the baseline visit
3. Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
4. Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
5. Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
6. Pregnant and lactating women and those who are presently planning to get pregnant
7. Those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT01638234
Study Brief:
Protocol Section:
NCT01638234