Status:
COMPLETED
Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
Lead Sponsor:
Medy-Tox
Conditions:
Nasolabial Folds
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Vo...
Detailed Description
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.
Eligibility Criteria
Inclusion
- Male or female, 18 to 75 years of age.
- Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.
Exclusion
- Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
- Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT03753152
Start Date
April 2 2018
End Date
October 16 2019
Last Update
July 28 2020
Active Locations (1)
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1
HuaShan hospital Fudan University
Shanghai, China