Herbal Ointment in Treating Atopic Dermatitis Topically

Launched by EN CHU KONG HOSPITAL · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new herbal ointment made from traditional Chinese medicine to treat atopic dermatitis, also known as eczema. Atopic dermatitis is a long-lasting skin condition that causes redness, itching, and inflammation. The trial aims to see if this herbal ointment, applied to the skin, can help improve symptoms for patients diagnosed with atopic dermatitis while monitoring for any side effects.

To participate in the trial, you must be between 18 and 65 years old and have atopic dermatitis that affects less than 10% of your body. You should also be in good health overall and not currently taking certain medications or treatments for your skin condition. If you join, you will undergo treatment with the herbal ointment and have your symptoms closely monitored. You’ll need to agree to follow the study rules and sign an informed consent form. This trial is an opportunity to potentially benefit from a new treatment while contributing to important research on managing atopic dermatitis.

Gender

ALL

Eligibility criteria

• 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.