Microneedle Patch for Psoriatic Plaques

Psoriasis Clinical Trial

Official title:

Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02955576
• Other study ID #: VC16DISI0128
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2016
• Last updated: November 14, 2016
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: The Catholic University of Korea
• Contact: Jung Min Bae, MD, PhD
• Phone: 82-31-249-8209
• Email: jminbae[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Administration, Topical
• Psoriasis

Intervention

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.
• 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.

Other:
• Control
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The adverse effects of microneedle patch	It will be assessed by patient-report.	Baseline, 1 week, 2 weeks	Yes