Microneedle Patch for Psoriatic Plaques
Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Korea, Republic of, 16247
- Recruiting
- St. Vincent's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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.
|
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
Sponsor
Investigators
- Study Chair: Jung Min Bae, MD, PhD, The Catholic University of Korea
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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.