Herbal ointment for treating atopic dermatitis
Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
This study is testing a herbal ointment made from a plant to see if it can help people with atopic dermatitis feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | En Chu Kong Hospital Academic / other |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT06850311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with mild to severe atopic dermatitis affecting less than 10% of their body surface area.
Not a fit: Patients with a history of hypersensitivity to herbal treatments or those with extensive skin involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from atopic dermatitis with fewer side effects than conventional therapies.
How similar studies have performed: While there is historical use of herbal remedies in treating atopic dermatitis, this specific approach is novel and has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Taipei City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.