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The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. |
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| Patch group | Active Comparator | All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches. |
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| Microneedle patch group | Experimental | All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle HA patch | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The adverse effects of microneedle patch | It will be assessed by patient-report. | Baseline, 1 week, 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung Min Bae, MD, PhD | Contact | 82-31-249-8209 | jminbae@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jung Min Bae, MD, PhD | The Catholic University of Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Recruiting | Suwon | Gyeonggi-do | 16247 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40165568 | Derived | 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. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Patch | Device | 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. |
|
| Control | Other | All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied. |
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