Clinical trial NCT01585220: Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasolabial Fold
Keywords: WSRS
GAIS
HA filler
filler
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 69
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: WSRS
timeFrame: 24 weeks after the injection
Secondary outcomes:
measure: WSRS
timeFrame: 2, 8, 16, 24 weeks after the injection
measure: WSRS
timeFrame: 2, 8, 16 weeks after the injection
measure: GAIS
timeFrame: 2, 8, 16, 24 weeks after the injection
measure: GAIS
timeFrame: 2, 8, 16, 24 weeks after the injection
measure: WSRS
timeFrame: 2, 8, 16, 24 weeks after the injection
measure: WSRS
timeFrame: 2, 8, 16, 24 weeks after the injection
measure: Number of adverse events in subjects
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chan Yeong Heo
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Saik Bang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.