Adding Auricular Acupuncture to Xiao-Feng-San Decoction for Treating Atopic Dermatitis

Last updated: March 24, 2025
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Overall Status: Completed

Phase

N/A

Condition

Allergies & Asthma

Hives (Urticaria)

Atopic Dermatitis

Treatment

Sham auricular acupuncture

Auricular acupuncture

Clinical Study ID

NCT06492902
270/HDDD-DHYD
  • Ages 18-65
  • All Genders

Study 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-blinded, randomized, sham-controlled study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with atopic dermatitis (AD) according to the American Academy ofDermatology guidelines and classified as mild to moderate.

  • Classified under Traditional Medicine as exhibiting wind-dampness-heatmanifestations and prescribed Xiao-Feng-San decoction.

  • Voluntary informed consent.

Exclusion

Exclusion Criteria:

  • Presence of other active skin diseases or skin infections requiring systemictreatment within the past four weeks or that would interfere with the properassessment 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 fourweeks.

  • Use of targeted biologic treatments within the past five half-lives (if known) orwithin the past 12 weeks, whichever is longer.

  • Use of phototherapy treatment, laser therapy, tanning booth sessions, or extendedsun exposure that could affect disease severity or interfere with diseaseassessments 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 topicalcorticosteroids (TCS), topical calcineurin inhibitors (TCIs), or topicalphosphodiesterase-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 underinvestigation 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 weeksafter the intervention.

  • Any history or current conditions that, in the investigator's assessment, wouldimpede the participant's involvement in the study, the adherence to treatment, theevaluation of treatment efficacy, or pose risks to the participant during the studyparticipation.

Study Design

Total Participants: 156
Treatment Group(s): 2
Primary Treatment: Sham auricular acupuncture
Phase:
Study Start date:
July 15, 2024
Estimated Completion Date:
March 23, 2025

Study 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 widely used in the treatment of mild to moderate AD exhibiting wind-dampness-heat manifestations. This study aims to investigate whether the addition of auricular acupuncture (AA), a form of acupuncture targeting points on the ear, enhances the efficacy of XFS in treating AD.

The trial is a multi-center, double-blinded, randomized, sham-controlled study involving participants diagnosed with mild to moderate AD exhibiting wind-dampness-heat manifestations according to TM and indicated for the use of XFS decoction. Participants will be randomly assigned to receive either AA or sham AA (placebo) in addition to XFS. Outcome measures will include the severity of AD symptoms, quality of life assessments, the need for antipruritic medication, total serum immunoglobulin E (IgE) levels, and adverse effects.

Through rigorous methodology and blinding procedures, this study seeks to provide evidence on the comparative efficacy of adjunct AA in enhancing the therapeutic effects of XFS for AD. The findings aim to contribute valuable insights into optimizing treatment strategies for AD using integrative approaches.

Connect with a study center

  • Traditional Medicine Hospital of Ho Chi Minh City

    Ho Chi Minh City, 70000
    Vietnam

    Site Not Available

  • University of Medical Center HCMC - Branch no.3

    Ho Chi Minh City, 700000
    Vietnam

    Site Not Available

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