Phase
Condition
Dermatitis, Atopic
Hives (Urticaria)
Eczema (Atopic Dermatitis - Pediatric)
Treatment
N/AClinical Study ID
Ages 1-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients and patients's parents or legal guardian have signed the informed consent.
Aged 1 to 12 years, diagnosed with atopic dermatitis according to Hanifin and Rajkacriteria
Patients experienced AD symptoms for at least 6 months
SCORAD index of 20-40, both inclusive
Exclusion
Exclusion Criteria:
Patient has other active non-AD skin diseases that could difficult the atopicdermatitis evaluation
Active cutaneous or extracutaneous infection (bacterial, viral, fungal) requiringsystemic treatment within 2 weeks of baseline (Localized molluscum contagiosum with <20 lesions and viral warts are generally not reasons for exclusion.)
Medical history of immunodeficiency syndrome, autoimmune disease or malignancy forsystemic therapies that modulate the immune system
Use of medications or treatments before baseline
Treated with corticosteroids, immunosuppressive treatment within 4 weeks ofbaseline
Treated with herbal medicines and health functional foods related to atopicdermatitis within 4 weeks of baseline
Treated with phototherapy treatments to atopic dermatitis within 4 weeks ofbaseline
Treated with probiotics within 4 weeks of baseline
Treated with systemic antibiotics within 2 weeks of baseline
Treated with topical steroids, topical immunomodulators, oral antihistamines, andtopical antibiotic within 1 week of baseline (inhaled corticosteroids for asthma,no washout required if doses is stable)
Medical history of infectious intestinal disease within 2 weeks before screening
History of hypersensitivity to components contained in study product (Lactobacillusrhamnosus)
Participation in any other investigational drug study in which receipt of aninvestigational study drug or health functional food within the past 4 weeks beforescreening (or, if known, administered within 5 times the half-life)
Patients who are considered to be unacceptable in this study under the opinion of theinvestigator
Study Design
Connect with a study center
Chung-Ang University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
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