AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female subjects aged 22 - 75 years (inclusive) of age at Screening.
✓. Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), as assessed by the blinded investigator at the site.
✓. Females of childbearing potential must have a negative urine pregnancy test and must agree to use an effective method of birth control throughout the entire study. Male subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom).
✓. Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
✓. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of entire investigation, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment).
✓. Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the investigator.
Exclusion criteria
✕. Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation
✕. History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
✕. History of hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic
What they're measuring
1
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset
Timeframe: Week 24
2
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset