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An Investigator-initiated, Multicenter, Subject-Assessor Blinded, Prospective, Parallel, Randomized, Sham-controlled, Exploratory Trial on the Alleviating Effect of Biodegradable Microneedle Acupuncture (BMA) on Mild to Moderate Atopic Dermatitis

An Investigator-initiated, Multicenter, Subject-Assessor Blinded, Prospective, Parallel, Randomized, Sham-controlled, Exploratory Trial on the Alleviating Effect of Biodegradable Microneedle Acupuncture (BMA) on Mild to Moderate Atopic Dermatitis

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0009870
Enrollment
184
Registered
2024-10-25
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-14

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

Conditions

None listed

Interventions

Medical Device : 184 participants with indications of the 10 acupoints, would be randomly assigned to the BMA treatment group or treatment group in a 1:1 ratio. The assigned participants would be tre

Sponsors

Dongshin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male or female patients aged 19-70 at the screening visit. 2) Patients diagnosed with atopic dermatitis by the Hanifin and Rajka crieria (more than 3 of 4 major symptoms and more than 3 of 23 minor symptoms). 3) Patients scored 10-40 in the Objective Scoring Atopic Dermatitis (SCORAD) index. 4) Patients who can read and write Korean and voluntarily submitted written consent with their signature.

Exclusion criteria

Exclusion criteria: 1) Patients with severe skin diseases other than atopic dermatitis or severe oozing and maceration of atopic lesions, who may affect the results of this study in the investigators’ opinion. 2) Patients with skin diseases due to other internal (e.g., liver diseases, renal failure, etc.), psychotic, or neurologic reasons who are expected to affect the results of this study. 3) Patients who have used systemic medications, including corticosteroids, antibiotics, immunosuppressants/immunomodulators (systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-?, etc.) within 1 month before the screening visit. Exceptionally, systemic antihistamines are allowed to administer during the trial within the dose on the randomization visit if they have been administered at a constant dose since 1 month before randomization. Reduction and discontinuation are permitted but increase is prohibited. 4) Other severe comorbidities (e.g., heart diseases, kidney diseases, liver diseases, respiratory diseases, malignancy, immunodeficiency, etc.) tdeemed inadequate by the principal investigator; the abnormality criteria for liver function is defined as aspartate transaminase (AST) or alanine transaminase (ALT) level 5 times higher than the upper limit of the analyzed institution, and those for renal function is defined as 3 times higher than the upper limit of the analyzed institution. 5) Severe or uncontrolled asthma (exacerbation of asthma requiring systemic corticosteroids for at least 3 days attacks more than 2 times per year) 6) Allergy to adhesives. 7) Pregnant, lactating women, or women planning pregnancy. 8) Others deemed inadequate by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Objective SCORAD index

Secondary

MeasureTime frame
Pruritus visual analogue scale (VAS);POEM(Patient-oriented Eczema Measure)

Countries

Korea, Republic of

Contacts

Public ContactSoo-Yeon Park

Dongshin University

swallow92@hanmail.net+82-61-338-7811

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026