Administration, Topical, Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques.
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.
Interventions
DEVICEMicroneedle 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.
DEVICEPatch
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.
OTHERControl
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of psoriasis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The adverse effects of microneedle patch | Baseline, 1 week, 2 weeks | It will be assessed by patient-report. |
Countries
South Korea
Contacts
Primary ContactJung Min Bae, MD, PhD
Outcome results
None listed