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The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction

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ClinicalTrials.gov Identifier: NCT02128204
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
SciVision Biotech Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Nosalabial Folds Correction Device: lidocaine contained hyaluronate facial dermal filler Device: hyaluronate facial dermal filler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Arm Intervention/treatment
Experimental: HYADERMIS LA Facial Dermal Implant
Subjects will be randomly assigned to receive experiment treatment, lidocaine contained hyaluronate facial dermal filler, in one side of the face.
Device: lidocaine contained hyaluronate facial dermal filler
HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.
Other Name: HYADERMIS LA Facial Dermal Implant

Active Comparator: Hya-Dermis Facial Dermal Implant
Subjects will be randomly assigned to receive control treatment, hyaluronate facial dermal filler, in one side of the face.
Device: hyaluronate facial dermal filler
Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.
Other Name: Hya-Dermis Facial Dermal Implant




Primary Outcome Measures :
  1. Adverse events report [ Time Frame: From the date of treatment to 14 days ]
    Any adverse events and abnormal physical parameters or reports occurred and disappeared should be monitored throughout the trial. The records should be assessed and keep on track of the severity of individual adverse events and correlation with the treatment. Severity assessment: To assess the level of severity by rating 0 (none), 1 (mild), 2 (median), and 3 (sever). Correlation assessment: Physicians evaluate the impact of adverse events for each individual and determine their causality of the treatment, giving score 0 (no correlated), 1 (low correlated), 2 (suspected correlated), 3 (most likely correlated ). Subjects will be given a medical diary after the treatment to record any adverse event and report to a physicians. Physicians keep following up adverse events until the symptoms stabilised.

  2. Pain Visual Analog Scale [ Time Frame: participants will be followed for the duration of treatment, an expected average of 10 minutes ]
    A quantification of the severity of pain experienced by the participants during the treatment. A scale of 100 mm horizontal line will be labeled by subjects to assess pain on both sides of the injected areas during the treatment. The one on the scale's extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by subjects.


Secondary Outcome Measures :
  1. Nasolabial folds severity scale [ Time Frame: From the baseline, 30 minutes post-treatment, and every follow-up at 1 and 2 weeks ]
    Based on Skin Aging Altas: Volume 2, Asian type photographs, taking gender and nasolabial folds into consideration to quantify the degree of nosalabial folds severity. A validated 8-point photographic scale scored the severity grade from 0 (absent) 7 (extreme) will be used to assess the severity.

  2. Global aesthetic improvement scale [ Time Frame: 30 minutes post-treatments and follow-ups at 1 and 2 weeks ]
    To quantify the level of overall aesthetic improvement and so giving a scale from 1 (worse), 2 (no change), 3 (improved), and 4 (much improved), and 5 (very much improved).

  3. Pain Visual Analog Scale [ Time Frame: 15, 30, 45, and 60 minutes post-treatment ]
    A quantification of the severity of pain experienced by the participants after the treatment. A scale of 100 mm horizontal line will be labeled by subjects to assess pain on both sides of the injected areas at 15, 30, 45, and 60 minutes post-treatment. The one on the scale's extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by subjects.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 25 to 60 years of age and of any sex who is willing to receive nasolabial folds correction by intradermal injection procedures
  • Have approximately symmetrical nasolabial folds with a nasolabial folds severity grade of 2-4 and the grade difference between two sides is less than 1
  • Agree to refrain from undergoing invasive aesthetic treatments in the injective areas 12 months after the injections
  • Agree to refrain from undergoing other physical or chemical aesthetic treatments in the injective areas 3 months after the injections
  • If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
  • Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures

Exclusion Criteria:

  • Have history or active dermal diseases, inflammation, or any related disease
  • Had permanent or semi-permanent implantation on nasolabial areas
  • Had invasive aesthetic treatments or surgeries history 6 months before the treatments
  • Had physical or chemical aesthetic treatments 1 months before the study starts
  • Have history of coagulation defect diseases and still take aspirin, anticlotting, or blood activating medications 1 week before the treatments
  • Have Adams-Stokes syndromes, wolff-prkinson-white syndromes, severe sinus node, the atrioventricular node dysfunction, or the blocked ventricular
  • Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
  • Have a known history of allergic reactions like hypersensitivity to lidocaine or other anaesthetics
  • Have poor compliance with the study or follow-up schedule

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128204


Locations
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Taiwan
Aesthetic Center of Yuan's General Hospital
Kaohsiung City, Taiwan, 80249
Sponsors and Collaborators
SciVision Biotech Inc.
Investigators
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Principal Investigator: Chao-Hong Liu, M.D. Department of Dermatology, Yuan's General Hospital

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Responsible Party: SciVision Biotech Inc.
ClinicalTrials.gov Identifier: NCT02128204     History of Changes
Other Study ID Numbers: RDCT-YDL
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action