NCT02955576

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

November 2, 2016

Last Update Submit

November 14, 2016

Conditions

PsoriasisAdministration, Topical

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The adverse effects of microneedle patch

    Baseline, 1 week, 2 weeks

Study Arms (3)

Control group

PLACEBO COMPARATOR

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

Other: Control

Patch group

ACTIVE COMPARATOR

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

Device: Patch

Microneedle patch group

EXPERIMENTAL

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

Device: Microneedle HA patch

Interventions

Microneedle HA patchDEVICE

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.

Microneedle patch group
PatchDEVICE

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.

Patch group
ControlOTHER

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

Control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Related Publications (1)

  • Ju HJ, Kim JY, Jeong DH, Lee MS, Kim GM, Bae JM, Lee JH. Additional Use of Hyaluronic Acid-Based Dissolving Microneedle Patches to Treat Psoriatic Plaques: A Randomized Controlled Trial. Ann Dermatol. 2025 Apr;37(2):105-113. doi: 10.5021/ad.24.024.

    PMID: 40165568DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Jung Min Bae, MD, PhD

    The Catholic University of Korea

    STUDY CHAIR

Central Study Contacts

Jung Min Bae, MD, PhD

CONTACT

82-31-249-8209jminbae@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

November 1, 2017

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

KR(1)