Skip to content

A Clinical Trial to Evaluate Safety and Efficacy of Meridian Biodegradable Microneedle Patch for improving Psoriasis Vulgaris

A Prospective, Randomized, Sham-Control, Subject-Evaluator Blind, Exploratory Clinical Trial to Evaluate Safety and Efficacy of Biodegradable Microneedle Patch for improving Psoriasis Vulgaris

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0010007
Enrollment
80
Registered
2024-12-06
Start date
2024-12-12
Completion date
Unknown
Last updated
2024-12-09

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 40 patients with Psoriasis Vulgaris. In the upper extremities, lower extremities, and trunk of each patient, 2 bilateral dry skin lesions with similar size and

Sponsors

Dongshin University
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 with moderate psoriasis of the trunk and extremities that can be treated topically that has lasted at least 6 months 3) Patients with 2 Psoriasis Vulgaris lesions that are bilateral and have similar size and severity in the upper extremities, lower extremities, and trunk. 4) 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 active, growing or spreading psoriasis lesions 2) Patients with other inflammatory skin conditions in the psoriatic lesion area that may interfere with evaluation (e.g., atopic dermatitis, contact dermatitis, ringworm) 3) Patients who have used topical treatments on psoriatic lesions within 7 days of the screening visit (corticosteroids, vitamin D analogs, retinoids, PDE4 inhibitors, salicylic acid, pimecrolimus, tacrolimus) 4) Patients using systemic treatments for psoriasis within 4 weeks of the screening visit (methotrexate, retinoids, PDE4 inhibitors, corticosteroids (excluding inhaled, nasal, ear, or ocular), cyclosporine) 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) Allergy to adhesives. 7) Pregnant, lactating women, or women planning pregnancy. 8) Others deemed inadequate by the principal investigator.

Design outcomes

Primary

MeasureTime frame
mPASI(modified Psoriasis Area Severity Index)

Secondary

MeasureTime frame
Pruritus visual analogue scale (VAS);Physician’s Global Assessment (PGA);Dermatological Life Quality Index(DLQI);EQ-5D version (EQ-5D-5L) score

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