Evaluation of Filler Injection for Chin Profile Enhancement

Phase 4RecruitingNCT07777926

University of Pennsylvania20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chin Regression Chin Asymmetry Jawline Contour Deficit

Interventions

HA FillerDRUG

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Volume change of the lower face area at 90 days post-intervention

3D-images will be collected to determine change in volume from baseline (pre-intervention) to post-intervention (90 days)

Time frame: 90 days

Secondary Outcomes

Patient Reported Outcomes

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.