Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

A Randomized, Multi-center, Double Masked, Matched Pairs, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis as Compared to Restylane® in Correction of Nasolabial Fold

This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subeject diary and follow up visits.

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold
• Intervention / Treatment: Device: HA filler

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam
    • Seoul, Gangnam, Korea, Republic of, 135-710
      • Samsung Medical Center
  • Gyunggi
    • Seongnam, Gyunggi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women aged between 30 and 75
2. Subjects who wanting to correct his/her nasolabial fold and attaining grade 3 or 4 in the Wrinkle Severity Rating Scale(WSRS) of nasolabial fold
3. Subjects whose nasolabial folds are visually symmetric
4. Subjects who agreed to restrict any treatment for the wrinkle correction at the lower orbital rim area for the duration of the study
5. Subjects who can understand and comply with the instructions and all visit schedule
6. Subjects who voluntarily decided the participation of the study and signed the informed consent

Exclusion Criteria:

1. Subjects who had anti-coagulant therapy(excluding low-dose aspirin therapy(100mg, maximum 300mg/day dose)) within 2 weeks from the screening date
2. Subjects who had previous treatment at the lower orbital rim for wrinkle correction(e.g., face lift, soft tissue augmentation, medium depth peels, dermal photorejuvenation) within 6 months from screening date
3. Subjects who were treated calcium hydroxyapatite at the NLF area within a year from screening date
4. Subjects who had dermal augmentation permanent implants(e.g., silicone, Softform®) at the NLF area
5. Subjects who have a scar or skin lesion which can be affect to efficacy to the NLF area
6. Subjects who had anaphylaxis or severe combined allergy or allergy to lidocain or hyaluronic acid
7. Subjects who had a history of keloid formation or hypertrophic scar
8. Subjects who have a skin disorder or wound infection in the NLF area
9. Subjects who participated in other clinical trial within 30 days from screening date
10. The childbearing subjects who disagreed with medically acceptable contraception(e.g., condom, oral contraceptives continuing at least 3 months, contraceptives for injection or insertion, intrauterine contraceptive devices)
11. Pregnant or lactating subjects
12. Patients who are not eligible for this study at the medical discretion of the investigator

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	Device: HA filler; The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.
Active Comparator: Restylane®	Device: HA filler; The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WSRS	The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment	24 weeks after the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WSRS	The change between baseline and 2, 8, 16, 24 week WSRS evaluated by the investigator in charge of photographic assessment	2, 8, 16, 24 weeks after the injection
WSRS	The change between baseline and 2, 8, 16 week WSRS evaluated by the investigator in charge of live assessment	2, 8, 16 weeks after the injection
GAIS	The rate of subjects whose GAIS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks from the injection	2, 8, 16, 24 weeks after the injection
GAIS	The rate of subjects whose GAIS, evaluated by the subjects him/herselves, is 1 point or above after 2, 8, 16, 24 weeks from the injection	2, 8, 16, 24 weeks after the injection
WSRS	The rate of subjects whose change of WSRS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks of the injection	2, 8, 16, 24 weeks after the injection
WSRS	The rate of subjects whose change of WSRS, evaluated by the investigator in charge of photographic assessment, is 1 pointe or above after 2, 8, 16, 24 weeks of the injection	2, 8, 16, 24 weeks after the injection
Number of adverse events in subjects	Adverse events occured after informed consent, Adverse drug events, Serious adverse events, lab test, physical examination, vital signs	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Principal Investigator: Chan Yeong Heo, Seoul National University Bundang Hospital; Principal Investigator: Saik Bang, Samsung Medical Center

Publications and helpful links

General Publications

• Pak C, Park J, Hong J, Jeong J, Bang S, Heo CY. A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds. Arch Plast Surg. 2015 Nov;42(6):721-8. doi: 10.5999/aps.2015.42.6.721. Epub 2015 Nov 16.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2012
• Primary Completion (Actual): August 30, 2012
• Study Completion (Actual): October 30, 2012

Study Registration Dates

• First Submitted: April 24, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: WSRS; GAIS; HA filler; filler
• Other Study ID Numbers: MT_PRT_NLF01