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RECRUITINGPHASE2/PHASE3

Herbal Ointment in Treating Atopic Dermatitis Topically

Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

NCT06850311•En Chu Kong Hospital

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Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

En Chu Kong hospital

New Taipei City, Taiwan

Key Dates

Start Date

March 1, 2025

Primary Completion Date

March 1, 2027

Completion Date

April 1, 2027

Last Updated

February 27, 2025

Enrollment

ESTIMATED participants

Conditions

Atopic DermatitisAtopic Dermatitis (AD)Atopic Dermatitis (Eczema)Atopic Dermatitis EczemaTCMSkin DiseasesSkin Diseases, EczematousSkin Diseases, Genetic

Interventions

herbal ointment

DRUG

Placebo

DRUG

Contacts

Ms. Chen

CONTACT

886+(02)+27623456 #3118 11759@km.eck.org.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Herbal Ointment in Treating Atopic Dermatitis Topically

Inclusion Criteria

Exclusion Criteria

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