Actively Recruiting
Herbal Ointment in Treating Atopic Dermatitis Topically
Led by En Chu Kong Hospital · Updated on 2025-02-27
66
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin disorder. The current first-line recommended treatment for AD is the use of emollients, topical corticosteroids (TCS), and oral antihistamines if necessary. However, patients often have side effects like skin atrophy and telangiectasia. And there were plenty of herbal medicine which are beneficial to atopic dermatitis in ancient Chinese medicine books and records. Therefore, the purpose of this study is to develop a new topical application of traditional Chinese medicine and evaluate its clinical efficacy in AD patients. In human trial, 66 Subjects diagnosed as AD will be enrolled and treated with Sophora flavescens Aiton topical ointment. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis. The 1st year project: (1) Expect to enroll 66 clinical subjects of AD. (2) Evaluate subjects 'symptom and proceed herbal ointment treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis. The 2nd year project: (1) Completing enrollment of 66 clinical subjects of AD. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.
CONDITIONS
Official Title
Herbal Ointment in Treating Atopic Dermatitis Topically
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years old, female or male.
- Diagnosed with atopic dermatitis according to Hanifin & Rajka criteria.
- Atopic dermatitis involving less than 10% of body surface area.
- Investigator's Global Assessment (IGA) score of 2, 3, or 4 (mild to severe disease).
- Female patients of child-bearing age with a negative pregnancy test at screening.
- Female patients of child-bearing age agree to use approved birth control and not to breastfeed during the study.
- Agree to use a stable dose of an additive-free, basic bland emollient for at least 7 days before baseline.
- Willing to follow the study protocol and sign informed consent.
You will not qualify if you...
- History of hypersensitivity to herbal ointment or its ingredients.
- Receiving phototherapy or systemic therapy (e.g., immunosuppressants) within 30 days before the study.
- Used topical or oral treatments for dermatitis within 7 days before starting the study medication.
- Having significant concurrent diseases like hematologic abnormalities, severe uncontrolled metabolic syndrome, psychiatric disease, cancer, or AIDS.
- Abnormal liver or kidney function (AST/ALT > 3 times upper limit of normal, creatinine > 2.0 mg/dl).
- Women who are pregnant, breastfeeding, or planning pregnancy.
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Trial Site Locations
Total: 1 location
1
En Chu Kong hospital
New Taipei City, Taiwan, 237
Actively Recruiting
Research Team
M
Ms. Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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