Phase
Condition
Eczema (Atopic Dermatitis)
Dermatitis, Atopic
Allergy
Treatment
Placebo
herbal ointment
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Between 18 and 65 years old, female or male.
Atopic dermatitis fulfilling the diagnostic criteria of Hanifin&Rajka.
Atopic dermatitis involving <10% of BSA. (Base on the BSA result of Screening)
An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds tomild, moderate or severe disease. (Base on the IGA result of Screening)
Female patients of child-bearing age with negative pregnancy test at screening.
Female patients of child-bearing age that agree to continue using birth controlmeasures approved by the investigator and agree not to lactate for the duration ofthe study.
Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0) Willing to comply with study protocol and agree to sign an informed consent form.
Exclusion
Exclusion Criteria:
Having a history of topical or systematical hypersensitivity to herbal or itsexcipient (e.g. vehicle) in ointment
Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressiveagents) within 30 days.
Having used topical or oral therapy (e.g. topical corticosteroids, antibiotic, TCM)for dermatitis within 7 days before the first application of the study medication.
Having a significant concurrent disease, such as: significant abnormalities inhematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetesmellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer orAIDS.
Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).
Women who are lactating, pregnant or preparing to be pregnant.
Study Design
Connect with a study center
En Chu Kong hospital
New Taipei City, 237
TaiwanActive - Recruiting
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