Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

Nasolabial Fold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585220
• Other study ID #: MT_PRT_NLF01
• Status: Completed
• Phase: Phase 3
• Start date: February 9, 2012
• Est. completion date: October 30, 2012

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 30, 2012
• Est. primary completion date: August 30, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Fold

Intervention

Device:
• HA filler
The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WSRS	The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment	24 weeks after the injection
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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