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Who can participate in this investigational research study?
This research study is evaluating an investigational treatment to potentially increase volume in the mid face. You may be able to take part in this study if you:
- Are at least 22 years old
- Have a moderate to significant loss of volume in your mid face
What’s involved with study participation?
The study will involve 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).
How long is this investigational research study?
If eligible, participation can last up to 20 months.
What is the treatment being tested?
The investigational treatment is a gel filler delivered via injection.
What about my current medications?
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.
Does participating in this study cost me anything?
There is no cost to you to participate in the study.
Why did I disqualify?
Clinical research studies are designed in specific ways, and one or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.
Consider exploring options through investigational clinical research.