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The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction

NCT02128204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-01-21

No results posted yet for this study

Summary

The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital Institutional Review Board. The aim of this post-marketing study is to evaluate the safety and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds.

The study was estimated to be held half to one year including a 0-2 weeks screening period, a day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be obtained before volunteers enter screening period. If the volunteers meet all the criteria, they will be given a number to replace their name in the study. The participants will be randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial folds and control treatment, Hya-Dermis, in the other side of the face. The safety assessment evaluated any recorded adverse events following the device treatments either by blinded evaluator or subjects. The effectiveness of the treatment devices will be assessed by using photographic assessment, nasoalabial folds severity scale, global aesthetic improvement scale, and pain visual analog scale.

Conditions

  • Pain
  • Nosalabial Folds Correction

Interventions

DEVICE

lidocaine contained hyaluronate facial dermal filler

HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.

DEVICE

hyaluronate facial dermal filler

Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.

Sponsors & Collaborators

  • SciVision Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Chao-Hong Liu, M.D. · Department of Dermatology, Yuan's General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-07-31
Completion
2015-01-31

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 NCT02128204 on ClinicalTrials.gov