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

NCT ID: NCT02751034

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-01-31

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.

Conditions

Nasolabial Fold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neuramis® Deep Lidocaine

Neuramis® Deep Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection

Group Type: EXPERIMENTAL

Neuramis® Deep Lidocaine

Intervention Type: DEVICE

HA filler

Restylane® PERLANE-L

Restylane® PERLANE-L Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection

Group Type: ACTIVE_COMPARATOR

Restylane® PERLANE-L

Intervention Type: DEVICE

HA filler

Interventions

Neuramis® Deep Lidocaine

HA filler

Intervention Type: DEVICE

Restylane® PERLANE-L

HA filler

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoon Kang

Role: PRINCIPAL_INVESTIGATOR

Catholic University St. Paul Hospital

BeomJoon Kim

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang Univ. Medical Center

Locations

Catholic University St. Paul Hospital

Seoul, Dongdaemun-gu, South Korea

Chung-Ang Univ. Medical Center

Seoul, Dongjak-gu, South Korea

Countries

South Korea

Other Identifiers

MT_PRT_NLF02

Identifier Type: -

Identifier Source: org_study_id