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

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

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

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold
• Intervention / Treatment: Device: Neuramis® Deep Lidocaine; Device: Restylane® PERLANE-L

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongdaemun-gu
    • Seoul, Dongdaemun-gu, Korea, Republic of, 130-709
      • Catholic University St. Paul Hospital
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of, 156-755
      • Chung-Ang Univ. Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs	from baseline to 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Principal Investigator: Hoon Kang, Catholic University St. Paul Hospital; Principal Investigator: BeomJoon Kim, Chung-Ang Univ. Medical center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: filler; Wrinkle Severity Rating Scale; Global Aesthetic Improvement Scale; Hyaluronic acid filler; Nasolabial Fold
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: MT_PRT_NLF02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No