A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

Allergan221 enrolled

Overview

This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

221

Conditions

Chin Retrusion

Interventions

JUVÉDERM VOLUMA® XCDEVICE

JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chin retrusion * In good general health Exclusion Criteria: * Permanent facial implants on the face and/or neck * Received fat injections below the nose * Tattoos, piercings, beard, mustache, and/or scars on the face below the nose * Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years * Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years * Received dermal filler injections in the lips or in the mouth area in the last 12 months * Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months * Received botulinum toxin treatment below the nose in the last 6 months

Locations (14)

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California, United States

Skin Research Institute

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score

The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).

Time frame: Baseline (up to 30 days prior to randomization) to Month 6

Secondary Outcomes

Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire

The participant answered 10 question on the chin module of the FACE-Q about their satisfaction with their chin using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied and 4=Very Satisfied. The total score was transformed to a score of 0 (worse) to 100 (best). A positive change from Baseline indicates improvement.

Time frame: Baseline (up to 30 days prior to randomization) to Month 6

Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator

The evaluating investigator assessed the participant's chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.

Time frame: Baseline (up to 30 days prior to randomization) to Month 6

Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants

The participants who received JUVÉDERM VOLUMA® XC, assessed their chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.

Time frame: Baseline (up to 30 days prior to randomization) to Month 6

Data from ClinicalTrials.gov

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