A human study to evaluate the effectiveness and safety of propolis extract on skin condition improvement in children with atopic dermatitis: a randomized, double-blind, parallel, placebo-controlled study
- Conditions
- Diseases of the skin and subcutaneous tissue
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
1) Subject who voluntarily agrees to participate and subjects and their parents (or legal representatives) sign in informed consent form
2) The ages of between 4 and 65 with intermittent or persistent symptoms of atopic dermatitis for more than 6 months
1) Subjects who have systemic diseases such as skin diseases except for atopic dermatitis, immunodeficiency, autoimmune diseases, cancer, etc.
2) Use of systemic antibiotics, corticosteroids, or immunosuppressants related to atopic dermatitis within 1 month of the first visit
3) Use of medication related atopic dermatitis such as antihistamines, herbal medicines, or health functional foods within 1 month of the first visit
4) Presence of received phototherapy within 1 month of the first visit
5) History of hypersensitivity including ingredients (propolis, honey) or pollen in the placebo/test material, or severe food allergic reactions
6) Subjects who plan to participate in another clinical trial during current participation
7) Participation in another clinical trial within 1 month of the first visit
8) Subjects who, in the investigator's judgment, have a condition that would not allow to participate in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Markers of atopic dermatitis
- Secondary Outcome Measures
Name Time Method Adverse event, vital signs