Clinical trial NCT02751034: Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold
Official title: A Randomized, Multi-center, Double Blind, Intra-Individual Controlled, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis® Deep Lidocaine as Compared to Restylane® PERLANE-L in Correction of Nasolabial Fold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasolabial Fold
Keywords: Wrinkle Severity Rating Scale
Global Aesthetic Improvement Scale
Hyaluronic acid filler
filler
Nasolabial Fold
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds

Detailed description: This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.

Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.

Eligibility criteria: Inclusion Criteria:

1. Male and female aged between 30 and 70 years, inclusive
2. Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale
3. Subjects with visually symmetrical bilateral nasolabial folds
4. Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial
5. Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial
6. Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form

Exclusion Criteria:

1. Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
2. Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening
3. Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
4. Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
5. Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
6. Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products
7. Subjects with a history of a hypertrophic scar or keloid
8. Subjects with a skin disease or wound infection at the investigational medical device injection site
9. Subjects who participated in another clinical trial within 30 days prior to screening
10. Pregnant or breastfeeding women or women of childbearing potential who are not using medically acceptable contraception or not consenting to practice birth control from screening to the end of trial
11. Subjects who are otherwise determined by the investigator as ineligible for this study

Primary outcomes:
measure: Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
timeFrame: from baseline to 24 weeks
Secondary outcomes:
measure: Change on Wrinkle Severity Rating Scale as evaluated by an investigator
timeFrame: from baseline to 8, 16, 24 weeks
measure: Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator
timeFrame: from baseline to 8, 16, 24 weeks
measure: Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
timeFrame: from baseline to 8, 16 weeks
measure: Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters
timeFrame: from baseline to 8, 16, 24 weeks
measure: Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator
timeFrame: 8, 16, 24 weeks after the injection
measure: Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject
timeFrame: 8, 16, 24 weeks after the injection
measure: Visual Analogue Scale as evaluated by a subject
timeFrame: at 15, 30, 45, 60 minutes after the injection
measure: Vital signs, physical examination, laboratory tests and adverse events
timeFrame: from baseline to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic University St. Paul Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univ. Medical Center
state: Dongjak-gu
Study officials:
affiliation: Catholic University St. Paul Hospital
name: Hoon Kang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang Univ. Medical Center
name: BeomJoon Kim
role: PRINCIPAL_INVESTIGATOR
References: