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Safety and Efficacy Study of Lidocaine Mixed Hyaluronate on Nasolabial Folds Correction

NCT02006173 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Nasolabial Folds Correction
  • Pain

Interventions

DRUG

Lidocaine

Xylocaine is a 2 % lidocaine hydrochloride contained liquid anesthesia

DRUG

Normal Saline

Sponsors & Collaborators

  • SciVision Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Primary Completion
2015-07-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006173 on ClinicalTrials.gov