A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.
Inclusion Criteria:
- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.
Exclusion Criteria:
- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit