Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2016-09-30
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.
Control
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.
Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
Patch group
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches.
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.
Microneedle patch group
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches.
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.
Interventions
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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.
Control
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.
Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
Eligibility Criteria
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Inclusion Criteria
* 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
* A pregnant or lactating patient
* A patient who cannot understand the study or who does not sign the informed consent
19 Years
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Jung Min Bae
Clinical Assistant Professor
Principal Investigators
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Jung Min Bae, MD, PhD
Role: STUDY_CHAIR
The Catholic University of Korea
Locations
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St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Jung Min Bae, MD
Role: primary
References
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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.
Other Identifiers
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VC16DISI0128
Identifier Type: -
Identifier Source: org_study_id