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A clinical study of Digital Electric Fire-needling Acupuncture Device (EFNA) for Chronic Eczematous Dermatitis

Clinical Evaluation and Mechanistic Study of Electroacupuncture Needle Treatment for Chronic Inflammatory Hyperplastic Skin Diseases

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082503
Enrollment
Unknown
Registered
2024-03-30
Start date
2024-04-12
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic eczema, neurodermatitis

Interventions

EFNA Group:Electric Fire-needling Acupuncture Device
Control group:Halometasone cream for external use

Sponsors

Beijing University of Traditional Chinese Medicine Dongzhimen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Male or female participants aged between 18 and 70 years. 2.Patients meeting the diagnostic criteria for chronic eczema or neurodermatitis. 3.Patients with mild to moderate localized skin lesions. 4.Participants who voluntarily sign the informed consent form, agree to receive the study treatment, and are able to comply with scheduled follow-up visits.

Exclusion criteria

Exclusion criteria: 1.Skin lesions located in special anatomical areas, such as the breast, vulva, perianal region, or ear. 2.Use of systemic corticosteroids or immunomodulatory agents within 14 days prior to treatment. 3.Individuals with a scar-prone constitution (keloid tendency). 4.Patients with severe primary diseases involving the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems. 5.Patients with systemic debility, diabetes mellitus, malignant tumors, psychiatric disorders, connective tissue diseases, or bleeding tendency. 6.Pregnant or lactating women. 7.Participants currently enrolled in other clinical trials. 8.Other conditions judged by the investigators to make the participant unsuitable for inclusion in the clinical study.

Design outcomes

Primary

MeasureTime frame
The change in Eczema Area and Severity Index (EASI) score from baseline (?EASI);—

Secondary

MeasureTime frame
The change in Eczema Area and Severity Index (EASI) score from baseline (?EASI);Target skin lesion area and score;Visual Analog Itch (VAS) Score;Dermatological Quality of Life Index (DLQI) score;Score of Hamilton Anxiety Scale and Hamilton Depression Scale;Dermatoscopic appearance;Skin barrier function;Safety indicators:Fluctuations in respiration, blood pressure, heart rate, and body temperature;—

Countries

China

Contacts

Public ContactZhao Baixiao

Dongzhimen Hospital Affiliated with Beijing University of Chinese Medicine

773814596@qq.com+86 130 7019 0632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026