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

March 24, 2025 updated by: An Hoa Tran, MD., MSc., University of Medicine and Pharmacy at Ho Chi Minh City

Efficacy of Adding Auricular Acupuncture to Xiao-Feng-San for Treating Atopic Dermatitis Exhibiting Wind-Dampness-Heat Manifestations According to Traditional Medicine: A Multi-Center, Double-Blinded, Randomized, Sham-Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • University of Medical Center HCMC - Branch no.3
      • Ho Chi Minh City, Vietnam, 70000
        • Traditional Medicine Hospital of Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XFS + AA
Auricular acupuncture in addition to Xiao-Feng-San.
Other: Auricular acupuncture
Auricular acupuncture is conducted weekly in four weeks using patches (four sessions), each with a square shape and a side length of 10 mm, along with sterilized needles measuring 0.25 x 1.3 mm. The patch with the needle will remain in place for one week.
Placebo Comparator: XFS + Sham AA
Sham auricular acupuncture in addition to Xiao-Feng-San.
Other: Sham auricular acupuncture
Sham auricular acupuncture is conducted weekly for four weeks using patches (four sessions), each with a square shape and a side length of 10 mm. The patches will not contain any needles and will remain in place for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Scoring Atopic Dermatitis (SCORAD) score
Time Frame: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
The SCORAD index is a tool used to assess atopic dermatitis (AD) severity. It combines objective measures of lesion extent and intensity with subjective evaluations of symptoms like pruritus and sleep loss. Calculated using the formula: A/5 + 7B/2 + C, where A represents lesion extent (0-100 points), B rates six objective symptoms (0-18 points), and C measures subjective symptoms on a 10-cm scale (0-20 points), the total score ranges from 0 to 103 with higher scores indicating more severe AD.
At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Dermatology Life Quality Index (DLQI) Score
Time Frame: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
The DLQI consists of 10 questions assessing patients' perceptions of how skin diseases have affected various aspects of their health-related quality of life over the past week. Each question is scored from 0 to 3 points, resulting in a total DLQI score ranging from 0 to 30. Higher scores indicate a greater impact on quality of life.
At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
Change in the Number of Antihistamine Tablets Used
Time Frame: Weekly throughout the four-week period (Week 1, Week 2, Week 3, Week 4)
The number of antihistamine tablets used per week by patients, as needed to relieve pruritus, is recorded.
Weekly throughout the four-week period (Week 1, Week 2, Week 3, Week 4)
Changes in Total Serum Immunoglobulin E (IgE) Levels
Time Frame: At randomization and after four weeks (Week 0, Week 4)
Total serum IgE levels are collected in the morning, measured in IU/ml.
At randomization and after four weeks (Week 0, Week 4)
Proportion of intervention-related adverse effects (AEs)
Time Frame: Up to four weeks
Expected AEs for auricular acupuncture include pain at the insertion site, local discomfort, local skin irritation (itching and redness), local inflammation and bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions. Additionally, any unexpected AEs associated with this procedure will also be documented and monitored.
Up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Principal Investigator: Nga Th Tran, MD,MSc, University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Actual)

March 23, 2025

Study Completion (Actual)

March 23, 2025

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 270/HDDD-DHYD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Auricular acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe