A 12 week, randomized, double-blind, placebo-controlled clinical trial of RHT-3201 for the evaluation of efficacy and safety on the children with atopic dermatitis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002202

Enrollment

100

Registered

2017-01-26

Start date

2014-11-03

Completion date

Unknown

Last updated

2019-03-11

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 : The participants enrolled in this study was assigned to 2 groups by double-blind randomization Test group: RHT-3201 1stick /day or dilution on water, 12 weeks Placebo group: place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who provided a signed written informed consent form 2) All children aged between 1 and 12 years 3) All children scored SCORAD(SCORing of Atopic Dermatitis) is between 25 and 50(Moderate)

Exclusion criteria

Exclusion criteria: 1) Subjects with serious systemic disease such as skin disease, immune deficiency, Maladie auto-immune or cancer except for atopic dermatitis 2) Subjects taking systemic antibiotics, Corticosteroids or immunosuppressive drug related to atopic dermatitis within 4 weeks 3) Subjects taking antihistamines, oriental medicine or health functional food to related atopic dermatitis within 2 weeks 4) Subjects taking Light therapy within 4 weeks 5) Subjects planning to participate in the other clinical study 6) Subjects participated in any clinical trial within 4 weeks 7) Subjects which in the opinion investigator could affect preclude evaluation of response

Design outcomes

Primary

Measure	Time frame
After 12weeks, SCORAD(SCORing of Atopic Dermatitis) total score	—

Secondary

Measure	Time frame
The quantity of a local used steriod ;Quality of Life of Parents of Children with Atopic Dermatitis;After 6weeks, SCORAD(SCORing of Atopic Dermatitis) total score;SCORAD objective score;SCORAD subjective(???, ????) score;IGA; Investigator’s Global Assessment;total IgE, Specific IgE(milk, egg, House dust mite, D1, D2), eosinophil counts, ECP, IL-4, IL-10, IL-31, CRP, TNF-a, TARC/CCL17	—

Countries

Korea, Republic of

Contacts

Public ContactSooyeon Bang

Ajou University Hospital

se7en23@naver.com+82-31-219-4405

Outcome results