Evaluation of Filler Injection for Chin Profile Enhancement

Purpose

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.

Conditions

  • Chin Regression
  • Chin Asymmetry
  • Jawline Contour Deficit

Eligibility

Eligible Ages
Between 22 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 22-55 - Patients interested in chin profile enhancement. - Participants must sign the informed consent form.

Exclusion Criteria

  • Prior filler for facial contouring - Filler injection within the past 12 months or during duration of study - Prior facial cosmetic surgery (i.e.. facelift) - Prior facial trauma (i.e.. orbital fracture) - Pregnant or breastfeeding at the time of injection (initial visit) - Planned dental work within next 2 weeks - The following contraindications: patients with known hypersensitivity or severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies, gram-positive bacterial protein allergies, lidocaine allergies or other local anesthetics of the amide type - Patients with known bleeding disorders

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Filler 		HA filler to chin region
  • Drug: HA Filler
    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.

Recruiting Locations

Penn Medicine
Philadelphia, Pennsylvania 19104

More Details

Status
Recruiting
Sponsor
University of Pennsylvania

Study Contact

Aamirah McCutchen
215-360-0652
aamirah.mccutchen@pennmedicine.upenn.edu