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
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0002202
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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)
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method After 12weeks, SCORAD(SCORing of Atopic Dermatitis) total score
- Secondary Outcome Measures
Name Time Method 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