Microneedle Patch for Psoriatic Plaques

November 14, 2016 updated by: Jung Min Bae, The Catholic University of Korea

Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Recruiting
        • St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.
Other: Control

All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.

Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
Active Comparator: Patch group
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches.
Device: Patch

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.
Experimental: Microneedle patch group
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches.
Device: Microneedle HA patch

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Study Chair: Jung Min Bae, MD, PhD, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC16DISI0128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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