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

Phase 3

Completed

• Conditions: Nasolabial Fold
• Interventions: Device: Neuramis® Deep Lidocaine; Device: Restylane® PERLANE-L

• Registration Number: NCT02751034
• Lead Sponsor: 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

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 Timeline

• Study Start: 2013-06
• Primary Completion: 2013-08
• Study Completion: 2014-01
• Study First Submitted: 2015-04-21
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Study First Posted: 2016-04-26
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuramis® Deep Lidocaine	Neuramis® Deep Lidocaine	Neuramis® Deep Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection
Restylane® PERLANE-L	Restylane® PERLANE-L	Restylane® PERLANE-L Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs	from baseline to 8, 16 weeks
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
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 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
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator	8, 16, 24 weeks after the injection
Vital signs, physical examination, laboratory tests and adverse events	from baseline to 24 weeks

Trial Locations

Locations (2)

Chung-Ang Univ. Medical Center; 🇰🇷 Seoul, Dongjak-gu, Korea, Republic of

Catholic University St. Paul Hospital; 🇰🇷 Seoul, Dongdaemun-gu, Korea, Republic of