Psoriasis Clinical Trial
Official title:
Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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