Atopic DermatitisNCT06922565
Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis
A study testing acupuncture in people with Atopic Dermatitis, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis: a Multicentre Randomised Sham-controlled Clinical Trial
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
- Being tested
- acupuncture, sham acupuncture
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
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 acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | Not described Receives: Device: acupuncture |
| sham acupuncture group | Sham comparator | Not described Receives: Device: sham acupuncture |
| Alternate control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).
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.
Measured: 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）
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.
Measured: 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)
Measured with neuECG, SKNA in µV
Measured: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).
Serum total IgE
Measured: 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）
Measured: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start3 Apr 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922565
- Sponsor's protocol ID
- 20250403
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis: a Multicentre Randomised Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06922565
- Acronym / sponsor ID
- 20250403
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 3 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Device: acupuncture |
| sham acupuncture group | Sham comparator | Device: sham acupuncture |
| Alternate control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the diagnostic criteria for moderate to severe atopic dermatitis;
Key exclusion criteria (4 listed)
- Patients who are in the acute onset of the disease and have erosions exudates and secondary infections;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureSubjects 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 | acupuncture group |
| sham acupunctureSterile 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. | Device | sham acupuncture group |
Primary outcome
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).
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.
6 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Atopic Dermatitis, run by Shanghai Yueyang Integrated Medicine Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.