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Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753152
Recruitment Status : Active, not recruiting
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Brief Summary:
This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Condition or disease Intervention/treatment Phase
Nasolabial Folds Device: experimental Device: comparator Not Applicable

Detailed Description:
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : April 20, 2019
Estimated Study Completion Date : October 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational medical device
Neuramis® Deep Lidocaine
Device: experimental
Neuramis® Deep Lidocaine

Active Comparator: Comparator device
YVOIRE® Volume Plus
Device: comparator
YVOIRE® Volume Plus




Primary Outcome Measures :
  1. WSRS improvement rate at Week 24 [ Time Frame: Week 24 ]
    WSRS improvement rate at Week 24


Secondary Outcome Measures :
  1. Change of WSRS from Week 4, 12, 24, 36, and 52 [ Time Frame: Week 4, 12, 24, 36, and 52 ]
    Change of WSRS from Week 4, 12, 24, 36, and 52

  2. WSRS improvement rate on Week 4, 12, 36, and 52 [ Time Frame: Week 4, 12, 36, and 52 ]
    WSRS improvement rate on Week 4, 12, 36, and 52

  3. GAIS improvement rate on Week 4, 12, 24, 36, and 52 [ Time Frame: Week 4, 12, 24, 36, and 52 ]
    GAIS improvement rate on Week 4, 12, 24, 36, and 52



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female, 18 to 75 years of age.
  2. Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.

Exclusion Criteria:

  1. Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
  2. Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.

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): NCT03753152


Locations
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China
HuaShan hospital Fudan University
Shanghai, China
Sponsors and Collaborators
Medy-Tox
Investigators
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Principal Investigator: Jinhua XU Huashan Hospital

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03753152    
Other Study ID Numbers: MT07-CN16NLF701
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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