Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold

Launched by MEDY-TOX · Apr 21, 2016

Keywords

ClinConnect Summary

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.

Gender

ALL

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