Herbal ointment for treating atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy of a topical herbal ointment made from Sophora flavescens Aiton in treating patients with atopic dermatitis (AD). The study will enroll 66 participants aged 18 to 65 who have been diagnosed with AD and will assess their symptoms before and after treatment. Participants will receive either the herbal ointment or a placebo, and the study will monitor for any adverse events. The goal is to determine the clinical effectiveness of this traditional Chinese medicine approach in managing AD symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Between 18 and 65 years old, female or male.
2. Atopic dermatitis fulfilling the diagnostic criteria of Hanifin\&Rajka.
3. Atopic dermatitis involving \<10% of BSA. (Base on the BSA result of Screening)
4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)
5. Female patients of child-bearing age with negative pregnancy test at screening.
6. Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the 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 Criteria:

1. Having a history of topical or systematical hypersensitivity to herbal or its excipient (e.g. vehicle) in ointment
2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
3. 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.
4. Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
5. Having abnormal liver or renal function (AST/ALT \>3 x ULN, creatinine \>2.0 mg/dl).
6. Women who are lactating, pregnant or preparing to be pregnant.

Where it's running

• En Chu Kong hospital
  New Taipei City, Taiwan Recruiting

Study contacts

• Study coordinator: Ms. Chen
• Email: 11759@km.eck.org.tw
• Phone: 886+(02)+27623456 #3118

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.