Microneedle Patch for Psoriatic Plaques

The Catholic University of Korea

Status: Unknown

Conditions: Psoriasis; Administration, Topical

Treatments: Device: Microneedle HA patch; Device: Patch; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02955576

VC16DISI0128

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Control

Patch group

Active Comparator group

Description:

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

Treatment:

Device: Patch

Microneedle patch group

Experimental group

Description:

All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches.

Treatment:

Device: Microneedle HA patch