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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT01840605
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 7 and 15 years
* Patients giving assent and whose legal guardian giving informed consent
* Outpatients
* Patients diagnosed as atopic dermatitis
* Patients who require the treatment with topical corticosteroid on areas other than face, head and neck
* Patients whose diaries can be properly maintained
* Patients who have 2 grades or more pruritus score
Exclusion Criteria:
* Patients with bronchial asthma who require concomitant use of the corticosteroid
* Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy
* Patients with current or previous history of drug hypersensitivity
* Patients who have been treated with Bepotastine besilate in the past
* Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied
* Patients who have spastic disease such as epilepsy
* Patients who concurrently have renal function abnormalities that may cause safety problems
* Patients who do not give consent to use birth control
* Pregnant patients, at risk of pregnancy or breastfeeding
* Patients who had participated in any clinical trial in the last 12 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
15 Years
Study:
NCT01840605
Study Brief:
Protocol Section:
NCT01840605