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Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold

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ClinicalTrials.gov Identifier: NCT02751034
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Brief Summary:
The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds

Condition or disease Intervention/treatment Phase
Nasolabial Fold Device: Neuramis® Deep Lidocaine Device: Restylane® PERLANE-L Phase 3

Detailed Description:

This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.

Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double Blind, Intra-Individual Controlled, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis® Deep Lidocaine as Compared to Restylane® PERLANE-L in Correction of Nasolabial Fold
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neuramis® Deep Lidocaine
Neuramis® Deep Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection
Device: Neuramis® Deep Lidocaine
HA filler

Active Comparator: Restylane® PERLANE-L
Restylane® PERLANE-L Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection
Device: Restylane® PERLANE-L
HA filler




Primary Outcome Measures :
  1. Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs [ Time Frame: from baseline to 24 weeks ]

Secondary Outcome Measures :
  1. Change on Wrinkle Severity Rating Scale as evaluated by an investigator [ Time Frame: from baseline to 8, 16, 24 weeks ]
  2. Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator [ Time Frame: from baseline to 8, 16, 24 weeks ]
  3. Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs [ Time Frame: from baseline to 8, 16 weeks ]
  4. Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters [ Time Frame: from baseline to 8, 16, 24 weeks ]
  5. Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator [ Time Frame: 8, 16, 24 weeks after the injection ]
  6. Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject [ Time Frame: 8, 16, 24 weeks after the injection ]
  7. Visual Analogue Scale as evaluated by a subject [ Time Frame: at 15, 30, 45, 60 minutes after the injection ]
  8. Vital signs, physical examination, laboratory tests and adverse events [ Time Frame: from baseline to 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female aged between 30 and 70 years, inclusive
  2. Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale
  3. Subjects with visually symmetrical bilateral nasolabial folds
  4. Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial
  5. Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial
  6. Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form

Exclusion Criteria:

  1. Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
  2. Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening
  3. Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
  4. Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
  5. Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
  6. Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products
  7. Subjects with a history of a hypertrophic scar or keloid
  8. Subjects with a skin disease or wound infection at the investigational medical device injection site
  9. Subjects who participated in another clinical trial within 30 days prior to screening
  10. Pregnant or breastfeeding women or women of childbearing potential who are not using medically acceptable contraception or not consenting to practice birth control from screening to the end of trial
  11. Subjects who are otherwise determined by the investigator as ineligible for this study

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): NCT02751034


Locations
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Korea, Republic of
Catholic University St. Paul Hospital
Seoul, Dongdaemun-gu, Korea, Republic of, 130-709
Chung-Ang Univ. Medical Center
Seoul, Dongjak-gu, Korea, Republic of, 156-755
Sponsors and Collaborators
Medy-Tox
Investigators
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Principal Investigator: Hoon Kang Catholic University St. Paul Hospital
Principal Investigator: BeomJoon Kim Chung-Ang Univ. Medical Center

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT02751034     History of Changes
Other Study ID Numbers: MT_PRT_NLF02
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medy-Tox:
Wrinkle Severity Rating Scale
Global Aesthetic Improvement Scale
Hyaluronic acid filler
filler
Nasolabial Fold

Additional relevant MeSH terms:
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Lidocaine
Hyaluronic Acid
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
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents