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

Not Applicable

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score	Baseline (up to 30 days prior to randomization) to Month 6	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire	Baseline (up to 30 days prior to randomization) to Month 6	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.
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	Baseline (up to 30 days prior to randomization) to Month 6	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.
Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants	Baseline (up to 30 days prior to randomization) to Month 6	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.

Locations (14): Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
🇺🇸
San Diego, California, United States
Skin Research Institute
🇺🇸
Coral Gables, Florida, United States
Baumann Cosmetic and Res. Institute
🇺🇸
Miami Beach, Florida, United States
Research Institute of the Southeast
🇺🇸
West Palm Beach, Florida, United States
DeNova Research
🇺🇸
Chicago, Illinois, United States
Callender Dermatology and Cosmetic Center
🇺🇸
Glenn Dale, Maryland, United States
SkinCare Physicians of Chestnut Hill
🇺🇸
Chestnut Hill, Massachusetts, United States
St Louis University Medical Center Dept. of Dermatology
🇺🇸
Saint Louis, Missouri, United States
Image Dermatology, PC
🇺🇸
Montclair, New Jersey, United States
Williams Plastic Surgery Specialists
🇺🇸
Latham, New York, United States
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Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
🇺🇸San Diego, California, United States