Status:
COMPLETED
Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
Lead Sponsor:
Medy-Tox
Conditions:
Mid Face Volume Loss
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.
Detailed Description
This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female su...
Eligibility Criteria
Inclusion
- Male or female 20 to 75 years of age
- Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale
Exclusion
- Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
- Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2020
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT03754413
Start Date
May 29 2018
End Date
March 9 2020
Last Update
March 19 2021
Active Locations (1)
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1
Beijing Hopsital
Beijing, China