Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

NCT01585220 | Completed Phase 3

• 1 other identifier: MT_PRT_NLF01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nasolabial Fold

Keywords

WSRS; GAIS; HA filler; filler

Outcome Measures

Primary Outcomes (1)

• WSRS

  The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment

  24 weeks after the injection

Secondary Outcomes (7)

• WSRS

  2, 8, 16, 24 weeks after the injection

• WSRS

  2, 8, 16 weeks after the injection

• GAIS

  2, 8, 16, 24 weeks after the injection

• GAIS

  2, 8, 16, 24 weeks after the injection

• WSRS

  2, 8, 16, 24 weeks after the injection

Study Arms (2)

Neuramis

EXPERIMENTAL

Device: HA filler

Restylane®

ACTIVE COMPARATOR

Device: HA filler

Interventions

HA filler DEVICE

The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.

Neuramis; Restylane®

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 30 and 75
• 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
• Subjects whose nasolabial folds are visually symmetric
• Subjects who agreed to restrict any treatment for the wrinkle correction at the lower orbital rim area for the duration of the study
• Subjects who can understand and comply with the instructions and all visit schedule
• Subjects who voluntarily decided the participation of the study and signed the informed consent

You may not qualify if:

• Subjects who had anti-coagulant therapy(excluding low-dose aspirin therapy(100mg, maximum 300mg/day dose)) within 2 weeks from the screening date
• 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
• Subjects who were treated calcium hydroxyapatite at the NLF area within a year from screening date
• Subjects who had dermal augmentation permanent implants(e.g., silicone, Softform®) at the NLF area
• Subjects who have a scar or skin lesion which can be affect to efficacy to the NLF area
• Subjects who had anaphylaxis or severe combined allergy or allergy to lidocain or hyaluronic acid
• Subjects who had a history of keloid formation or hypertrophic scar
• Subjects who have a skin disorder or wound infection in the NLF area
• Subjects who participated in other clinical trial within 30 days from screening date
• 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)
• Pregnant or lactating subjects
• Patients who are not eligible for this study at the medical discretion of the investigator

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (2)

Samsung Medical Center

Seoul, Gangnam, 135-710, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Gyunggi, 463-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26618119 DERIVED

Study Officials

• Chan Yeong Heo

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Saik Bang

  Samsung 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 24, 2012
• First Posted: April 25, 2012
• Study Start: February 9, 2012
• Primary Completion: August 30, 2012
• Study Completion: October 30, 2012
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

KR (2)