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

NCT02751034 | Completed Phase 3

• 1 other identifier: MT_PRT_NLF02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Nasolabial Fold

Keywords

Wrinkle Severity Rating Scale; Global Aesthetic Improvement Scale; Hyaluronic acid filler; filler; Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

• Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs

  from baseline to 24 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

Neuramis® Deep Lidocaine

EXPERIMENTAL

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

Device: Neuramis® Deep Lidocaine

Restylane® PERLANE-L

ACTIVE COMPARATOR

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

Device: Restylane® PERLANE-L

Interventions

Neuramis® Deep Lidocaine DEVICE

HA filler

Neuramis® Deep Lidocaine

Restylane® PERLANE-L DEVICE

HA filler

Restylane® PERLANE-L

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
• 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
• Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
• Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
• Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
• Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products
• Subjects with a history of a hypertrophic scar or keloid
• Subjects with a skin disease or wound infection at the investigational medical device injection site
• Subjects who participated in another clinical trial within 30 days prior to screening
• 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
• Subjects who are otherwise determined by the investigator as ineligible for this study

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (2)

Catholic University St. Paul Hospital

Seoul, Dongdaemun-gu, 130-709, South Korea

Location

Chung-Ang Univ. Medical Center

Seoul, Dongjak-gu, 156-755, South Korea

Location

Study Officials

• Hoon Kang

  Catholic University St. Paul Hospital

  PRINCIPAL INVESTIGATOR

• BeomJoon Kim

  Chung-Ang Univ. Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 26, 2016
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)