Clinical trial NCT05529836: Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema
Official title: Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema: Study Protocol for a Randomized Multicenter, Sham Electroacupuncture, Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Lichenified Atopic Dermatitis
Keywords: Electroacupuncture (EA)
Chronic atopic eczema
Pruritus Severity
Randomized controlled trial
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eczema is a common allergic skin disease, accounting for about 15 to 30% of dermatological outpatients. Pruritus as one of the most painful symptoms is often underestimated in terms of the problems that it can cause, which creates the vicious loop of itching, scratching, and lichenification. Therefore, further research into practical and safe treatments that eliminate itchy symptoms and enhance skin protection is the key to overcoming chronic atopic eczema. Acupuncture has been utilized clinically in China for thousands of years due to its benefits of being practical, affordable, and simple to execute. With modern science and technology advancements, electroacupuncture (AE) has become widely used in China's public hospitals to treat chronic atopic eczema. This trial aims to objectively evaluate the clinical efficacy and safety of the electroacupuncture antipruritic technique in chronic atopic eczema pruritus and to obtain its high-level clinical evidence for the popularization and application of electroacupuncture clinical treatment of chronic atopic eczema.

Detailed description: As a common allergic skin disease, the incidence of eczema is increasing year by year, accounting for about 15 \~ 30% of the dermatological outpatients. Pruritus is one of the most painful symptoms of eczema. Patients often form a vicious circle of "pruritus -- scratching -- mossy transformation" because they can't stand it. Research on safe and effective anti-pruritus program has become the key to treatment. Inheriting the experience of Xia's surgery in Shanghai, the team proposed the core pathogenesis of "blood heat and dampness heat", formulated the treatment principle of "cooling blood dehumidification", selected acupoints Quchi (LI4), Hegu (LI11), Xuehai (SP10) and Sanyi jiao (SP6), and used the original acupuncture anti-pruritus technique (modified by acupuncture anesthesia technique) to treat chronic eczema with clinical advantages. Small sample Pilot study showed that acupuncture antipruritic technique significantly reduced the visual analogue scale (VAS) score of patients with chronic eczema, which was significantly better than sham EA group and non-EA group. This project adopts the multicenter, randomized, including false contrast design, objective, normative evaluation of acupuncture for chronic eczema itching itching and technology to improve situation, clinical efficacy and safety, obtain exact clinical evidence, further to form suitable for standardization, popularization and application in wide range of chronic eczema itching technology clinical acupuncture specification.

Eligibility criteria: Inclusion Criteria:

1. Meeting the TCM syndrome differentiation criteria and Western medicine diagnostic criteria for chronic eczema;
2. between the ages of 18 and 65;
3. BSA score \< 10%;
4. Agree to participate in clinical trial observation and cooperate with regular visitors;
5. Sign and date the informed consent;

Exclusion Criteria:

1. Patients who have been systematically treated with hormones or immunosuppressants within two weeks;
2. Recipients who are not durable to acupuncture;
3. Patients with severe secondary infection symptoms, including local skin infection and systemic infection of other organs;
4. Women who are pregnant, breastfeeding or planning to become pregnant during the trial;
5. Diabetes mellitus or patients with severe heart, liver and kidney disease;
6. Those who have received other research drugs or participated in other clinical trials within 3 months;
7. Unable to cooperate with the research for any reason, such as: language comprehension, unable to go to the research center for treatment, etc.;
8. Patients with generalized eczema, skin lesions all over the body and inconvenient for acupuncture;
9. Acute onset of chronic eczema.
10. BSA score ≥10%.

Primary outcomes:
measure: the change from baseline in Visual Analogue Scale (VAS) scores
timeFrame: week0, week1, week2
Secondary outcomes:
measure: Eczema Area and Severity Index, EASI
timeFrame: week0, week1, week2
measure: Dermatology Life Quality Index, DLQI
timeFrame: week1, week2
measure: Serum total IgE
timeFrame: week1, week2
Other outcomes:
Locations:
Study officials:
References: