Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT02721368
Eligibility Criteria:
Inclusion Criteria:
1. Subject aged between 35 and 65.
2. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level
Exclusion Criteria:
1. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
2. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
3. Those who has thin skin in the mid-facial area
4. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
\<Extension Study\>
Inclusion Criteria:
1. Participated in the pivotal study and completed the end of study visit
2. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
Exclusion Criteria
1. Those who have following procedual history between completion of the pivotal study and entry of extension study
\- facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting
2. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT02721368
Study Brief:
Protocol Section:
NCT02721368