Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis

NCT ID: NCT06922565

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

acupuncture group

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

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.

sham acupuncture group

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: DEVICE

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.

Alternate control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

20250403

Identifier Type: -

Identifier Source: org_study_id