Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medy-Tox.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01585220
First received: April 24, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Nasolabial Fold
Device: HA filler
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • WSRS [ Time Frame: 24 weeks after the injection ] [ Designated as safety issue: No ]
    The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment


Secondary Outcome Measures:
  • WSRS [ Time Frame: 2, 8, 16, 24 weeks after the injection ] [ Designated as safety issue: No ]
    The change between baseline and 2, 8, 16, 24 week WSRS evaluated by the investigator in charge of photographic assessment

  • WSRS [ Time Frame: 2, 8, 16 weeks after the injection ] [ Designated as safety issue: No ]
    The change between baseline and 2, 8, 16 week WSRS evaluated by the investigator in charge of live assessment

  • GAIS [ Time Frame: 2, 8, 16, 24 weeks after the injection ] [ Designated as safety issue: No ]
    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

  • GAIS [ Time Frame: 2, 8, 16, 24 weeks after the injection ] [ Designated as safety issue: No ]
    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

  • WSRS [ Time Frame: 2, 8, 16, 24 weeks after the injection ] [ Designated as safety issue: No ]
    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

  • WSRS [ Time Frame: 2, 8, 16, 24 weeks after the injection ] [ Designated as safety issue: No ]
    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

  • Safety [ Time Frame: During all study periods ] [ Designated as safety issue: Yes ]
    Adverse events occured after informed consent, Adverse drug events, Serious adverse events, lab test, physical examination, vital signs


Estimated Enrollment: 69
Study Start Date: February 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585220

Contacts
Contact: Kyuhwa Lee 070-8666-6963 ext 6963 khlee@medy-tox.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Gangnam, Korea, Republic of, 135-710
Principal Investigator: Saik Bang         
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyunggi, Korea, Republic of, 463-707
Principal Investigator: Chan yeong Heo         
Sponsors and Collaborators
Medy-Tox
Investigators
Principal Investigator: Chan Yeong Heo Seoul National University Bundang Hospital
Principal Investigator: Saik Bang Samsung Medical Center
  More Information

No publications provided

Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT01585220     History of Changes
Other Study ID Numbers: MT_PRT_NLF01
Study First Received: April 24, 2012
Last Updated: April 24, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Medy-Tox:
WSRS
GAIS
HA filler
filler

ClinicalTrials.gov processed this record on October 19, 2014