Microneedle Patch for Psoriatic Plaques

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

Detailed Description
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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.

Official Title
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Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis

Conditions
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Psoriasis, Administration, Topical

Intervention / Treatment
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* Device: Microneedle HA patch
* Device: Patch
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. | Other: Control<br>* All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.<br>|
| Active Comparator: Patch group<br>All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches. | Device: Patch<br>* The patch were made of hyaluronic acid with no microneedles to rule out the occlusion effect of microneedle HA patch. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches. Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied. The hyaluronic acid patch was prepared at Raphas Co., Ltd. (Cheonan, South Korea) for this clinical trial, not for sale.<br>|
| Experimental: Microneedle patch group<br>All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches. | Device: Microneedle HA patch<br>* The microneedle HA patch were made of hyaluronic acid with microneedles which can enhance the drug permeation. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches. Microneedle HA patch (Therapass®, RMD-6.5A) was prepared at Raphas Co., Ltd. (Cheonan, South Korea). Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of psoriasis | 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. | Baseline, 1 week, 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse effects of microneedle patch | It will be assessed by patient-report. | Baseline, 1 week, 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis