Pain Clinical Trial
Official title:
Safety and Efficacy Study of Hya-Dermis Mixed With Lidocaine Injection for the Improvement of Nasolabial Folds
This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed,
single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan
University Hospital Research Ethics Committee. The aim of this post-marketing study is to
evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the
effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential
loss to follow-up, the minimum enrollment was statistically determined to be 40 patients.
The study was estimated to be held one and half year including a 0-2 weeks screening period,
a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms
will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF)
severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets
of randomized numbers are used, patient numbers and treatment numbers. Participants with odd
patient numbers will be assigned to nasolabial group and those with even patient numbers
will be assigned to nasolabial&cheekbone group. Participants receive experiment treatment
(Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with
normal saline) in the other side of the face randomly depending on the treatment numbers.
Both physicians and participants are only blind to the treatment assignment. 30 minutes
after the injection, a post-photograph will be used to evaluate NLF severity scale scores
and global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the
Visual Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction
will be collected from patients. The effectiveness analyses compare NLF severity scale
scores and GAIS based on photograph records from physicians, as well as participant
questionnaires for each group on every visit. The safety assessment evaluates any recorded
adverse events following the device treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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