Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: acupuncture, sham acupuncture.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis: a Multicentre Randomised Sham-controlled Clinical Trial
Overview
This study used a multicentre parallel three-armed randomised sham-controlled clinical trial methodology in order to objectively and normatively assess the efficacy of acupuncture on Quchi the Sea of Blood the Foot Sanli and the Sanyinjiao in the treatment of moderate-to-severe atopic dermatitis so as to obtain high-level evidence-based medical evidence. This study adopts a multi-centre, parallel, three-armed, randomized, sham-controlled clinical trial method, and will be conducted at Yueyang Hospital of Integrative Medicine affiliated with Shanghai University of Traditional Chinese Medicine, Huashan Hospital affiliated with Fudan University, and Seventh People's Hospital affiliated with Shanghai University of Traditional Chinese Medicine. Eligible patients with moderate-to-severe AD will be divided into three groups using stratified block randomisation in the ratio of 2:2:1: the acupuncture group, the sham-acupuncture group and the waitlisted control group. The total observation period is 9 weeks, including a 1-week introduction period, a 4-week treatment period and a 4-week follow-up period.
Interventions
- Device acupuncture
Subjects in the acupuncture group received traditional acupuncture. The needles were inserted to induce a sense of 'getting qi' and left in place for 30 minutes. - Device sham acupuncture
Sterile disposable retractable needles and a fake placebo acupuncture device are used for sham acupuncture. The acupuncturist attached the base of the sham acupuncture device to the acupoints, and then inserted sterile disposable blunt-tipped retractable needles into the tubes; when the blunt tips touched the skin, the needles retracted into the handles, and there was no sensation of getting qi.
Primary outcome measures
- SCORing atopic dermatitis（SCORAD） [Time frame: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).]
Secondary outcome measures (6)
- Patient Oriented Eczema Measure (POEM) [Time frame: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).]
- Dermatology Life Quality Index（DLQI） [Time frame: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).]
- Peak Pruritus Numerical Rating Scale（PP-NRS） [Time frame: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).]
- Skin Peripheral sympathetic nerve activity (SKNA) [Time frame: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).]
- Serum total IgE [Time frame: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).]
- Peripheral blood serum cytokines（IL-4,IL-13,IL-31,IL-33,INF-α） [Time frame: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).]
Eligibility criteria
Inclusion criteria
- Meet the diagnostic criteria for moderate to severe atopic dermatitis;
- Age ≥18 and ≤75 years old gender is not limited; ③ Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4; ④ Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
- Patients who are in the acute onset of the disease and have erosions exudates and secondary infections;
- Patients who have participated in other clinical studies in the past 3 months or are participating in other clinical studies; ③ Patients with severe haematological diseases (e.g. platelet count <50×109 /L) and other serious diseases that may affect operation and efficacy;
- Current systematic use of glucocorticosteroids discontinued for less than 7 days; immunosuppressants (cyclosporine methotrexate tretinoin etc.) discontinued for less than 1 month; dulprevirizumab discontinued for less than 1 month JAK inhibitors discontinued for less than 2 weeks;
- Women who are pregnant or breastfeeding; ⑥ Patients with a history of acupuncture treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06922565 · 20250403