Microneedle Patch for Psoriatic Plaques

Not Applicable

• Conditions: Psoriasis; Administration, Topical
• Interventions: Device: Patch; Other: Control; Device: Microneedle HA patch

• Registration Number: NCT02955576
• Lead Sponsor: The Catholic University of Korea

Brief Summary

The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques.

Detailed Description

As a novel minimally invasive approach, microneedle-mediated transdermal drug delivery has received increased attention. Microneedle patch effectively penetrates the skin barrier of the stratum corneum and create efficient pathways for the delivery of drugs.

A randomized controlled trial based on split-body was planned to evaluate the efficacy of enhanced transdermal delivery of topical agent by hyaluronic acid (HA)-fabricated microneedle patch in psoriatic plaques. Six psoriatic plaques in a patient will be randomized to either microneedle HA patch, patch, or control groups. Patch group is planned for rule out the occlusion effect of patches. All lesions will be treated with topical agent and patches daily for 2-week period. The severity of psoriasis will be grated with modified PASI score and the clinical improvement will be assessed as % from baseline every week. Overall 20 patients with 120 psoriatic plaques will be enrolled.

Study Timeline

• Study Start: 2016-09
• Status Verified: 2016-11
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15
• Primary Completion: 2017-02
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age: older than 19
• A patient with psoriasis
• A patient with symmetrical psoriatic lesions
• A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
• A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages

Exclusion Criteria

• Age: lower than 20
• A pregnant or lactating patient
• A patient who cannot understand the study or who does not sign the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patch group	Patch	All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches.
Control group	Control	All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.
Microneedle patch group	Microneedle HA patch	All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches.

Primary Outcome Measures

Name	Time	Method
The improvement of psoriasis	Baseline, 1 week, 2 weeks	The severity of psoriasis will be graded with modified PASI score, and the improvement will be assessed as % from baseline by using a computer program.

Secondary Outcome Measures

Name	Time	Method
The adverse effects of microneedle patch	Baseline, 1 week, 2 weeks	It will be assessed by patient-report.

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of