Status:
COMPLETED
Adding Auricular Acupuncture to Xiao-Feng-San Decoction for Treating Atopic Dermatitis
Lead Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study aims to compare the efficacy of adding auricular acupuncture to Xiao-Feng-San decoction versus Xiao-Feng-San decoction in treating atopic dermatitis. The trial is a multi-center, double-bli...
Detailed Description
Atopic dermatitis (AD) is a chronic inflammatory skin condition that affects a significant number of individuals worldwide. In Traditional Medicine (TM), Xiao-Feng-San (XFS), a TM formula, has been wi...
Eligibility Criteria
Inclusion
- Diagnosed with atopic dermatitis (AD) according to the American Academy of Dermatology guidelines and classified as mild to moderate.
- Classified under Traditional Medicine as exhibiting wind-dampness-heat manifestations and prescribed Xiao-Feng-San decoction.
- Voluntary informed consent.
Exclusion
- Presence of other active skin diseases or skin infections requiring systemic treatment within the past four weeks or that would interfere with the proper assessment of atopic dermatitis lesions.
- Use of systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4) inhibitors, interferon-gamma (IFN-γ), and mycophenolate mofetil within the past four weeks.
- Use of targeted biologic treatments within the past five half-lives (if known) or within the past 12 weeks, whichever is longer.
- Use of phototherapy treatment, laser therapy, tanning booth sessions, or extended sun exposure that could affect disease severity or interfere with disease assessments within the past four weeks.
- Use of systemic anti-infectives within the past four weeks.
- Use of herbal medicine within the past 12 weeks.
- Use of topical treatments for AD, including but not limited to topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), or topical phosphodiesterase-4 (PDE-4) inhibitors within the past one week.
- History of alcohol or substance addiction within the past six months.
- Prior experience with acupuncture.
- Presence of existing injuries or lesions at the auricular acupoints under investigation in this study.
- Concurrent participation in other clinical trials or use of other therapies for AD.
- Pregnancy, lactation, or planning to become pregnant within approximately 12 weeks after the intervention.
- Any history or current conditions that, in the investigator's assessment, would impede the participant's involvement in the study, the adherence to treatment, the evaluation of treatment efficacy, or pose risks to the participant during the study participation.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06492902
Start Date
July 15 2024
End Date
March 23 2025
Last Update
March 26 2025
Active Locations (2)
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1
University of Medical Center HCMC - Branch no.3
Ho Chi Minh City, Vietnam, 700000
2
Traditional Medicine Hospital of Ho Chi Minh City
Ho Chi Minh City, Vietnam, 70000