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Atopic DermatitisNCT06492902

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

A study testing Auricular acupuncture in people with Atopic Dermatitis, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Auricular acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
2 sitesVietnam
Study dates
15 Jul 2024to 23 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites
  • University of Medical Center HCMC - Branch no.3

    Ho Chi Minh City, 700000

  • Traditional Medicine Hospital of Ho Chi Minh City

    Ho Chi Minh City, 70000

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Being tested
Auricular acupuncture, Sham auricular acupuncture
Keywords
atopic dermatitis, traditional Chinese medicine, Xiao-Feng-San, auricular acupuncture, acupuncture
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auricular acupunctureOther

    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.

  • Sham auricular acupunctureOther

    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.

Study groups in NCT06492902
Study groupRoleWhat they receive
XFS + AAExperimentalAuricular acupuncture in addition to Xiao-Feng-San.
Receives: Other: Auricular acupuncture
XFS + Sham AAPlacebo comparatorSham auricular acupuncture in addition to Xiao-Feng-San.
Receives: Other: Sham auricular acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Scoring Atopic Dermatitis (SCORAD) score

    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.

    Measured: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)

Secondary outcomes (4)
  1. Changes in Dermatology Life Quality Index (DLQI) Score

    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.

    Measured: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)

  2. Change in the Number of Antihistamine Tablets Used

    The number of antihistamine tablets used per week by patients, as needed to relieve pruritus, is recorded.

    Measured: Weekly throughout the four-week period (Week 1, Week 2, Week 3, Week 4)

  3. Changes in Total Serum Immunoglobulin E (IgE) Levels

    Total serum IgE levels are collected in the morning, measured in IU/ml.

    Measured: At randomization and after four weeks (Week 0, Week 4)

  4. Proportion of intervention-related adverse effects (AEs)

    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.

    Measured: Up to four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start15 Jul 2024
  3. Primary completion23 Mar 2025
  4. Study completion23 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492902
Sponsor's protocol ID
270/HDDD-DHYD
Status last verified
Mar 2025
First submitted
1 Jul 2024
Last updated
26 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cai X, Sun X, Liu L, Zhou Y, Hong S, Wang J, Chen J, Zhang M, Wang C, Lin N, Li S, Xu R, Li X. Efficacy and safety of Chinese herbal medicine for atopic dermatitis: Evidence from eight high-quality randomized placebo-controlled trials. Front Pharmacol. 2022 Sep 27;13:927304. doi: 10.3389/fphar.2022.927304. eCollection 2022.

    PubMed 36238577
  • Trinh DTT, Bui MMP, Nguyen HT. The effects of auricular acupuncture at lung, shenmen, endocrine, adrenal points on adult eczema: a randomized trial. MedPharmRes 2023;7(1):47-52.

  • Park JG, Lee H, Yeom M, Chae Y, Park HJ, Kim K. Effect of acupuncture treatment in patients with mild to moderate atopic dermatitis: a randomized, participant- and assessor-blind sham-controlled trial. BMC Complement Med Ther. 2021 Apr 29;21(1):132. doi: 10.1186/s12906-021-03306-1.

    PubMed 33926433
  • Tan HY, Lenon GB, Zhang AL, Xue CC. Efficacy of acupuncture in the management of atopic dermatitis: a systematic review. Clin Exp Dermatol. 2015 Oct;40(7):711-5; quiz 715-6. doi: 10.1111/ced.12732. Epub 2015 Aug 24.

    PubMed 26299607
  • Lee HC, Park SY. Preliminary Comparison of the Efficacy and Safety of Needle-Embedding Therapy with Acupuncture for Atopic Dermatitis Patients. Evid Based Complement Alternat Med. 2019 Apr 23;2019:6937942. doi: 10.1155/2019/6937942. eCollection 2019.

    PubMed 31178916
  • Fukuda M, Kawada N, Kawamura H, Abo T. Treatment for atopic dermatitis by acupuncture. Adv Exp Med Biol. 2004;546:229-37. doi: 10.1007/978-1-4757-4820-8_17. No abstract available.

    PubMed 15584378
  • Sur B, Lee B, Yeom M, Hong JH, Kwon S, Kim ST, Lee HS, Park HJ, Lee H, Hahm DH. Bee venom acupuncture alleviates trimellitic anhydride-induced atopic dermatitis-like skin lesions in mice. BMC Complement Altern Med. 2016 Jan 29;16:38. doi: 10.1186/s12906-016-1019-y.

    PubMed 26825274
  • Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.

    PubMed 8435513
  • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

    PubMed 8033378
  • Cheng HM, Chiang LC, Jan YM, Chen GW, Li TC. The efficacy and safety of a Chinese herbal product (Xiao-Feng-San) for the treatment of refractory atopic dermatitis: a randomized, double-blind, placebo-controlled trial. Int Arch Allergy Immunol. 2011;155(2):141-8. doi: 10.1159/000318861. Epub 2010 Dec 22.

    PubMed 21196758
  • Tran NT, Tran AH, Trinh DT. Efficacy of herbal medicine Xiao-Feng-San combined with auricular acupuncture for atopic dermatitis: A randomized controlled trial. Integr Med Res. 2026 Jun;15(2):101256. doi: 10.1016/j.imr.2025.101256. Epub 2025 Sep 23.

    PubMed 41104111

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupuncture in people with Atopic Dermatitis, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492902, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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