A 8 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of IRT5 probiotics on atopic dermatitis in childre
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0000914
- Lead Sponsor
- Korea Yakult Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
1)subject who signs ICF with a legal representative who signs the informed consent form before participating in the study
2)subject aged between 5 years and 12 years with atopic dermatitis
3)subject with intermittent or continuous atopic dermatits symptom over 6 months
4)subject with SCORAD index between 25 and 50
1)subject with other systemic illnesses or dermatits history except AD
2)subject administrating immunosuppressant,antobiotics,corticosteroid, antihistaminic within 4 weeks
3)subject who has taken medicines,chinese medicine, health functional foods within 4 weeks for improvement of atopic dermatitis
4)subject with systemic phototherapy within 1 month
5)subject with probiotics within 2 weeks
6)subject who has taken scheduled for participating in another study during this study period or who had participated in other study within 4 weeks
7)Inappropriate subject decided by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SCORAD (SCORing of Atopic Dermatitis) score
- Secondary Outcome Measures
Name Time Method immunoglobulin A ;skin condition measurement(moisture, skin oil, skin-ph-meter);eosinophil ;total IgE ;eosinophil cationic protein