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A 12 week, RAndomized, Double-blind, Placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB&PG-F on atopic dermatitis in chidlren

A 12 week, RAndomized, Double-blind, Placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB&PG-F on atopic dermatitis in chidlren

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005646
Enrollment
100
Registered
2020-11-30
Start date
2019-12-18
Completion date
Unknown
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Experimental material (BRB&PG-F): 2 times per day, 2 tablets per dose, at morning and evening (total compound, 600 mg/day)

Sponsors

Ajou University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who agreed to participate in this trial and presented a document, voluntarily signed by the subject and the parent (or legal representative) 2) Those who aged 3 to 15 years 3) Those who have persistent atopic dermatitis symptoms for more than 6 months 4) Those who have SCORAD scores between 25 and 50 (moderate) at the time of screening and randomization

Exclusion criteria

Exclusion criteria: 1) Those who have skin disease other than atopic dermatitis, which impairs accurate evaluation of atopic dermatitis results such as irritant contact dermatitis, allergic contact dermatitis, infection (e.g., ohms) or psoriasis 2) Those who have skin or dermatitis (bacteria, viruses, fungi) that require full body treatment within 2 weeks of screening (except for localized water lions with fewer than 20 lesions and viral warts) 3) Those who have systemic diseases such as immune deficiencies, autoimmune diseases, cancer, etc. 4) Those who administered the following medicines or received the following treatment before screening A. Those who administered systemic antibiotics, corticosteroids and immunosuppressants within 2 weeks of screening B. Those who took herbal medicine, health function foods in relation to atopic dermatitis within 4 weeks of screening are {Demonne products (VSL#3) and lactobacillus products licensed for atopic dermatitis (Sake Probio65, Lactobacillus plantarum CJLP133, L. Rhamnosus IDCC3201)} C. Those who received phototherapy within 4 weeks of screening D. Those who administered local steroids, antihistamines, local immuno-suppressants, oral antihistamines or local antibiotics within a week of screening 5) Those who have infectious bowel disease history within 2 weeks of screening 6) Those who have an overreaction history in the ingredients of food for human application testing (e.g. mushrooms, balloon flower root, black rice and milk) 7) Those who participated in other clinical trials within 2 months of the start of this clinical trial (including a human application test) or have a plan to participate in another interventional clinical trial (including a human application trial) after the start of this human application trial 8) Those who considered as inappropriate for this clinical trial by the judgment of the investigator

Design outcomes

Primary

MeasureTime frame
SCORAD total score at week 12;SCORAD total score at week 6

Secondary

MeasureTime frame
Cytokines and immunological markers

Countries

Korea, Republic of

Contacts

Public ContactJihyun Moon

Ajou University Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026