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Not yet recruitingNCT06922565Updated Apr 10, 2025

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

An interventional study of acupuncture and sham acupuncture in Atopic Dermatitis, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's planned enrollment of 110 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 38 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    acupuncture group

    Device: acupuncture

  • Sham comparator
    sham acupuncture group

    Device: sham acupuncture

  • No intervention
    Alternate control group

Interventions

  • Deviceacupuncture

    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.

  • Devicesham 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.

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What researchers measure

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.

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

Secondary outcomes

  1. Patient Oriented Eczema Measure (POEM)

    Patients themselves assessed the frequency and severity of 7 symptoms occurring in the past 1 week, with each entry on a 5-point scale corresponding to a score of 0, 1, 2, 3, and 4. Scores ranged from 0 \~ 28, with higher scores indicating greater severity.

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

  2. Dermatology Life Quality Index(DLQI)

    The questionnaire contains 10 questions. Scores range from 0 to 30, with higher scores indicating a greater impact on quality of life.

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

  3. Peak Pruritus Numerical Rating Scale(PP-NRS)

    The PP-NRS is a patient self-report, with a score of 0 for no itching and 10 for the worst itching imaginable, with the patient scoring the worst itching experienced in the last 24 h. The PP-NRS is a patient self-report, with a score of 0 for no itching and 10 for the worst itching imaginable.

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

  4. Skin Peripheral sympathetic nerve activity (SKNA)

    Measured with neuECG, SKNA in µV

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

  5. Serum total IgE

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

  6. 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).

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06922565
Lead sponsor
Shanghai Yueyang Integrated Medicine Hospital
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
Apr 3, 2025 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Apr 10, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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