The HEIGHTEN Study is evaluating whether an investigational treatment works to potentially increase the volume of soft tissue in the mid face, which is called mid-face augmentation.
About the HEIGHTEN Study
The HEIGHTEN Study is evaluating whether an investigational treatment works to potentially increase the volume of soft tissue in the mid face, which is called mid-face augmentation.
Participation involves up to 14 clinic visits and up to 4 phone visits over the course of up to 20 months. Each participant will be in the study for up to 20 months: up to 1 month for screening, up to 1 month of study treatment, up to 12 months of follow-up after the initial/touch-up study treatment, and up to 6 months of follow-up after maintenance study treatment.
Eligible participants will randomly (by chance) be assigned to a study group with a 2:1 (67%) chance of receiving the investigational treatment versus control (an already approved treatment).
Participants will receive initial study treatment (investigational or control) at the beginning of the study and may choose to receive an optional touch-up study treatment 30 days later if agreed upon by both the participant and study doctor. Participants will have 2 follow-up visits (1 of which is a phone call) after initial study treatment, then a touch-up study treatment (optional) with 2 follow-up visits (1 of which is a phone call), plus 5 additional follow-up visits. At this point, participants may exit the study or opt for a maintenance study treatment with 5 follow-up visits (2 of which are phone calls).
Consider exploring options through investigational clinical research.