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

NCT06492902 | Completed

• 1 other identifier: 270/HDDD-DHYD
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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-blinded, randomized, sham-controlled study.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; traditional Chinese medicine; Xiao-Feng-San; auricular acupuncture; acupuncture

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Changes in Dermatology Life Quality Index (DLQI) Score

  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

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

• Changes in Total Serum Immunoglobulin E (IgE) Levels

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

• Proportion of intervention-related adverse effects (AEs)

  Up to four weeks

Study Arms (2)

XFS + AA

EXPERIMENTAL

Auricular acupuncture in addition to Xiao-Feng-San.

Other: Auricular acupuncture

XFS + Sham AA

PLACEBO COMPARATOR

Sham auricular acupuncture in addition to Xiao-Feng-San.

Other: Sham auricular acupuncture

Interventions

Auricular acupuncture OTHER

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.

XFS + AA

Sham auricular acupuncture OTHER

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.

XFS + Sham AA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (2)

University of Medical Center HCMC - Branch no.3

Ho Chi Minh City, 700000, Vietnam

Location

Traditional Medicine Hospital of Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (11)

• 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.

  PMID: 36238577 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33926433 BACKGROUND

• 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.

  PMID: 26299607 BACKGROUND

• 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.

  PMID: 31178916 BACKGROUND

• 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.

  PMID: 15584378 BACKGROUND

• 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.

  PMID: 26825274 BACKGROUND

• 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.

  PMID: 8435513 BACKGROUND

• 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.

  PMID: 8033378 BACKGROUND

• 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.

  PMID: 21196758 BACKGROUND

• 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.

  PMID: 41104111 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Nga Th Tran, MD,MSc

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 15, 2024
• Primary Completion: March 23, 2025
• Study Completion: March 23, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

VN (2)