Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold
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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 |
- 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
- 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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Kyuhwa Lee | 070-8666-6963 ext 6963 | khlee@medy-tox.co.kr |
| 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 | |
| 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 May 16, 2013