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A Clinical Trial to Evaluate Safety and Efficacy of Korean Meridian Biodegradable Microneedle Patch for improving Atopic Dermatitis Dryness

A Prospective, Multicenter, Randomized, Participant- and Assessor-Blinded, Sham-Controlled Clinical Trial to Evaluate the Efficacy of a Korean Medicine-Based Biodegradable Microneedle Patch for Improving Skin Symptoms in Patients with Atopic Dermatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009871
Enrollment
116
Registered
2024-10-25
Start date
2026-01-09
Completion date
Unknown
Last updated
2026-06-15

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 : This study will recruit 58 patients with atopic dermatitis. In the upper extremities, lower extremities, and trunk of each patient, 2 bilateral dry skin lesions with similar size and

Sponsors

Naju Dongshin University Korean Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants should satisfy all following 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 with 2 atopic dermatitis lesions that are bilateral and have similar size and severity in the upper extremities, lower extremities, and trunk. 4) Patients with an Objective Scoring Atopic Dermatitis (SCORAD) index of 10 to 40 5) Patients who can read and write Korean and voluntarily submitted written consent with their signature.

Exclusion criteria

Exclusion criteria: Patients who satisfy any criterion of the followings cannot participate in this study; 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 applied topical corticosteroids to treat the lesions of atopic dermatitis within 7 days before the screening visit. 4) 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. 5) 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. 6) Patients with a known allergy to Jaungo or its components (e.g., Lithospermi Radix, Angelicae Gigantis Radix, sesame oil, beeswax, pork fat, etc.) 7) Allergy to adhesives. 8) Pregnant, lactating women, or women planning pregnancy. 9) Others deemed inadequate by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Local scoring atopic dermatitis (L-SCORAD) index

Secondary

MeasureTime frame
Target Lesion Investigator’s Global Assessement, TL-IGA;Pruritus visual analogue sacle (VAS);Dryness visual analogue scale (VAS);Slee-p loss visual analogue sclae (VAS);Transepidermal Water Loss, TEWL;Objective scoring atopic dermatitis (SCORAD) index

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: Jun 21, 2026