Atopic dermatitis Skin and Connective Tissue Diseases
Conditions
Interventions
Fucoidans have been reported to have various pharmacological effects, including anti-cancer, anti-virus, anti-inflammatory, immunomodulatory, anti-pathogen adhesion/infection activities, antidiabetic,
Sponsors
Linkou Chang Gung Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity of atopic dermatitis measured using the Severity Scoring of Atopic Dermatitis (SCORAD) index on day 0 (baseline), week 6, week 12 (end of low-molecular-weight fucoidan/placebo), and week 16 (end of the trial) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following questionnaires were completed at baseline, week 6, week 12 and week 16: 1. Quality of life measured using the validated Chinese version of the Dermatology Life Quality Index (DLQI) questionnaire for patients over 16 years old, and the Children’s Dermatology Life Quality Index (CDLQI) questionnaire for patients under the age of 16 years old 2. Sleep quality measured using the validated Athens Insomnia Scale (AIS) Chinese version (CAIS-8) The following parameters related to the immune system were measured in blood samples at baseline, week 12, and week 16: 3. Parameters related to the immune system, including IgE, white blood cells, eosinophil, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin (IL)-4, IL-12, IL-13, interferon-? (IFN-?), and the percentage of CD4+ and CD8+ T cells. Blood samples from participants were sent to the department of Laboratory Medicine in Taoyuan Chang Gung Memorial Hospital for testing of IgE, WBC, eosinophil, ESR, CRP, AST, and ALT. For examination of lymphocyte subsets, samples were labeled with antibodies against CD4 and CD8 (BD Biosciences, San Jose, USA). The samples were analyzed by flow cytometry using appropriate isotype controls. Cytometry analyses were performed using BD FACSCanto™ II Clinical Flow Cytometry System equipped with FASDiva Software (BD Biosciences). Serum cytokines levels (IL-4, IL-12, IL-13, Interferon-?), were measured by an enzyme-linked immunosorbent assay (ELISA) using commercially available kits according to the manufacturer's instructions (Quantikine, R&D System, Minneapolis MN, USA). 4. The average frequency of using western medicine (steroid ointment or oral antihistamine) measured using patient-reported diaries on the days/week during baseline, weeks 1-6, weeks 7-12, and weeks 13-16 | — |
Countries
Taiwan
Contacts
Public ContactPin-Han Wang
Outcome results
None listed