The efficacy and safety of low-molecular-weight fucoidan in patients with atopic dermatitis: A randomized, double-blind, placebo-controlled trial

inkou Chang Gung Memorial Hospital0 个研究点目标入组 91 人开始时间: 2023年2月16日最近更新: 2023年2月27日

适应症

试验速览

暂无简介。

•1. Male and female patients between 4 and 60 years of age
•2. Evidence of itchy skin (or parental report of scratching or rubbing), combined with three or more of the following:
•2.1. History of involvement of the skin creases (e.g., fronts of the elbow, backs of knees, fronts of ankles, and areas around the neck or eyes)
•2.2. History of asthma or hay fever
•2.3. History of generally dry skin in the past year
•2.4. Onset in a child under two years of age
•2.5. Visible flexural dermatitis
•3. SCORing Atopic Dermatitis (SCORAD) score greater than or equal to 16 points
•4. Those who voluntarily agree to participate and sign the informed consent

•1. Other eczema disorders, such as contact dermatitis or seborrheic dermatitis, etc., assessed by a dermatologist
•2. Other dermatological diseases related to skin pruritus, assessed by a dermatologist
•3. Oral/injected steroids, leukotriene antagonists, immunosuppressants, systemic photochemotherapy, immunotherapy, allergen-specific immunotherapy, or Chinese herbal medicine within 1 month before enrollment
•4. Unable to take the study medicine as scheduled or cooperate in filling out the questionnaire and taking a blood test
•5. Allergy to fucoidan
•6. Hyperthyroidism history
•7. Suffering from serious infection requiring hospitalization(e.g., pneumonia, cellulitis, or sepsis) , assessed by a clinician
•8. Severe dysfunctions of the organ (e.g., heart failure, liver failure, liver cirrhosis, or renal failure (eGFR <60 mL/min/1.73 m2)), assessed by a clinician
•9. Women in pregnancy or in preparation for pregnancy, and those in lactation

发起方

inkou Chang Gung Memorial Hospital