Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume
This trial is active, not recruiting.
|Treatments||neuramis® volume lidocaine, juvederm® voluma® with lidocaine|
|Start date||January 2016|
|End date||December 2016|
|Trial size||144 participants|
|Trial identifier||NCT02721368, MT_PRT_MVD01|
The purpose of this study is to determine whether Neuramis® Volume Lidocaine is effective in the temporary restoring the mid-face volume.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Neuramis® Volume Lidocaine
Juvederm® Voluma® with Lidocaine
Improvement rate of the subject on the mid face volume deficit scale
time frame: 24 weeks
Improvement rate of the subject on the global aesthetic improvement scale
time frame: 48 weeks
Male or female participants from 35 years up to 65 years old.
Inclusion Criteria: 1. Male or female subject aged between 35 and 65. 2. Subject who wanting to correct his/her mid-face volume deficit. 3. Subject who agreed not to receive a cosmetic procedure or cosmetic surgery during the study period. 4. Subjects who voluntarily decided the participation of the study and signed the informed consent. Exclusion Criteria: 1. Subjects who had previous treatment at the mid-face for restoring volume. 2. Subjects who had skin lesion caused by congenital defect, trauma and lipodystrophy etc. 3. Subjects who had hypersensitivity to local anesthetic of amide type or lidocaine. 4. Pregnant, lactating subjects or the childbearing subjects who disagreed with medically acceptable contraception. 5. Subjects who have received any investigational product within 4 weeks prior to study participation and who are scheduled to take part in other clinical trial during the study period. 6. Subjects who had medical history such as anaphylaxis or severe complex allergy. 7. Subjects who had a mental disease which can be affect to this study or have severe disorder in the cardiovascular system, the digestive system, the respiratory system, the endocrine system and the central nervous system. 8. Patients who are not eligible for this study at the medical discretion of the investigator.
|Official title||Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume|
|Principal investigator||BeomJoon Kim|
|Description||This study is a multi-center, randomized, evaluator and subject blind, comparative medical device pivotal clinical trial. Efficacy and safety are evaluated at the appointed time that subject visit clinical site after injecting medical device.|
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