Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT07777926
The goal of this prospective study is to analyze volumetric changes in the lower face after hyaluronic acid filler injections over 90 days.
The primary aim of the study is to quantify volume change of the lower face rea over time after injection of filler. The secondary aim is to collect patient related outcomes (PROs) via FACE-Q.
Participants will receive hyaluronic acid filler injections (Restylane Lyft(for contouring of the chin. Each patient will receive FDA approved dosages of filler to the lower face region to treat chin regression or chin contouring, as per FDA approved indications.
Prior to injections patients will be imaged with 3-dimensional photogrammetry. Subjects will return post-injection in 2 weeks, 1 month, and 3 moths for re-imaging.
Interested in participating?
Request Info22 year–55 year
All sexes
Interventional
Phase 4
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive FDA approved dosages of filler to the lower face region to treat chin regression or contour the chin, as per FDA approved indications. Patients are limited to the maximum recommended injected dose per patient for the initial and re-treatment (touch-up) injections of 4 mL. The injected volume per injection site should not exceed 2mL, the maximum volume studied and established by the manufacturer. Prior to injections, patients will be imaged with 3-dimensional photogrammetry and take a validated survey questionnaire (FACE-Q). Subjects will return post-injection in 2 weeks, 1 month, and 3 months for re-imaging and FACE-Q survey completion.
Time frame: 90 days
3D-images will be collected to determine change in volume from baseline (pre-intervention) to post-intervention (90 days)
Time frame: 90 days
Patient-reported outcomes (PROs) will be assessed using FACE-Q questionnaires (FACE-Q), an aesthetics validated survey questionnaire, including appearance, satisfaction, psychological well-being, and treatment outcome domains. FACE-Q scores are transformed to a standardized scale ranging from 0 to 100, with higher scores generally indicating more favorable patient-reported outcomes within the measured domain.
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
3-Dimensional Volumetric Analysis of a Hyaluronic Filler Injection for Chin Profile Enhancement
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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