Clinical trial NCT06492902: Adding Auricular Acupuncture to Xiao-Feng-San Decoction for Treating Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
traditional Chinese medicine
Xiao-Feng-San
auricular acupuncture
acupuncture
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Scoring Atopic Dermatitis (SCORAD) score
timeFrame: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
Secondary outcomes:
measure: Changes in Dermatology Life Quality Index (DLQI) Score
timeFrame: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
measure: Change in the Number of Antihistamine Tablets Used
timeFrame: Weekly throughout the four-week period (Week 1, Week 2, Week 3, Week 4)
measure: Changes in Total Serum Immunoglobulin E (IgE) Levels
timeFrame: At randomization and after four weeks (Week 0, Week 4)
measure: Proportion of intervention-related adverse effects (AEs)
timeFrame: Up to four weeks
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University of Medical Center HCMC - Branch no.3
city: Ho Chi Minh City
country: Vietnam
facility: Traditional Medicine Hospital of Ho Chi Minh City
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Nga Th Tran, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.