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

NCT06922565 | Not Yet Recruiting DMC

• 1 other identifier: 20250403
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• SCORing atopic dermatitis（SCORAD）

  SCORAD range of 0 \~ 103 points.The condition is classified as mild, moderate or severe according to the score, with the higher the score, the more severe the condition.

  This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).

Secondary Outcomes (6)

• Patient Oriented Eczema Measure (POEM)

  This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).

• Dermatology Life Quality Index（DLQI）

  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）

  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)

  This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).

• Serum total IgE

  This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).

Study Arms (3)

acupuncture group

EXPERIMENTAL

Device: acupuncture

sham acupuncture group

SHAM COMPARATOR

Device: sham acupuncture

Alternate control group

NO INTERVENTION

Interventions

acupuncture 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.

acupuncture group

sham acupuncture 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.

sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Acupuncture Therapy

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)

Complementary Therapies; Therapeutics

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: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 10, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04