A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of KBL693 on atopic dermatitis in childre
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0005895
- Lead Sponsor
- Kobiolabs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 159
1) A person who agrees to participate in this clinical trial and has voluntarily signed a Informed consent form with his/her
parents (or legal representative).
2) A person who are over 2 years of age and under 16 years of age.
3) A person who have intermittent or persistent atopic dermatitis symptoms for more than six months
4) A person whose SCORAD score is 25 to 50 points (mild-modelate) in Visit 1 and 2.
5) A person diagnosed with atopic dermatitis according to the diagnosis criteria of Hanifin and Rajka.
1) A person who has severe skin diseases and systemic diseases other than atopic dermatitis.
2) A person who has administered systemic antibiotics, systemic corticosteroids, and antihistamines in relation to atopic
dermatitis within four weeks of the start of the clinical trial.
3) A person who administers systemic immunosuppressants within 12 weeks of the clinical trial.
4) A person who administers medicine, herbal medicine, and health functional foods to improve atopic dermatitis within one
week of the start of the clinical trial.
5) A person who has taken probiotics health functional foods, consistently fermented milk, and digestive (at least four times
a week) within one week of the start of the clinical trial.
6) A person who has received phototherapy within four weeks of the start of the clinical trial.
7) A person who has plans to participate in other clinical trials during clinical trial(excluding observational research).
8) A person who participated in other clinical trials within four weeks of the start of the clinical trial(excluding observational
research).
9) A person who is deemed unfit for the clinical trial by investigator.
10) A person who has an anamnesis of hypersensitivity to probiotics and pseudo-sequences.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scoring atopic dermatitis total score
- Secondary Outcome Measures
Name Time Method Scoring atopic dermatitis objective score;Scoring atopic dermatitis subjective score;IGA(Investigator’s Global Assessment);Eosinophil, ECP, Total IgE, cytokine(IL-4, IL-5, IL-10, IL-13, IL-17, IL-22, IFN-?, TGF-ß, TNF-a, CCL11(Eotaxin-1), CCL17(TARC), CCL22(MDC), CCL26(Eotaxin-3), CCL27(CTACK));Skin pH, Transepidermal water loss, moisture content;Use ratio and usage of local steroids;intestinal mycelium variation