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

Not Applicable

Completed

• Conditions: Chin Retrusion
• Interventions: Device: JUVÉDERM VOLUMA® XC

• Registration Number: NCT02833077
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-28
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-14
• Primary Completion: 2018-02-06
• Study Completion: 2018-10-11
• Disposition First Submitted: 2019-02-14
• Disposition First Submitted QC: 2019-02-14
• Disposition First Posted: 2019-02-18
• Status Verified: 2020-07
• Results First Submitted: 2020-07-10
• Results First Submitted QC: 2020-07-10
• Last Update Submitted: 2020-07-10
• Results First Posted: 2020-07-23
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Treatment then JUVÉDERM VOLUMA® XC	JUVÉDERM VOLUMA® XC	No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
JUVÉDERM VOLUMA® XC	JUVÉDERM VOLUMA® XC	JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined.

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.

Trial Locations

Locations (14)

Skin Research Institute; 🇺🇸 Coral Gables, Florida, United States

Baumann Cosmetic and Res. Institute; 🇺🇸 Miami Beach, Florida, United States

SkinCare Physicians of Chestnut Hill; 🇺🇸 Chestnut Hill, Massachusetts, United States

Williams Plastic Surgery Specialists; 🇺🇸 Latham, New York, United States

The Center for Dermatology, Cosmetics, & Laser Surgery; 🇺🇸 Mount Kisco, New York, United States

St Louis University Medical Center Dept. of Dermatology; 🇺🇸 Saint Louis, Missouri, United States

Image Dermatology, PC; 🇺🇸 Montclair, New Jersey, United States

Dermatology & Laser Center of Charleston Center for Clinical Research; 🇺🇸 Charleston, South Carolina, United States

Premier Clinical Research; Spokane Dermatology Clinic; 🇺🇸 Spokane, Washington, United States

Callender Dermatology and Cosmetic Center; 🇺🇸 Glenn Dale, Maryland, United States

Research Institute of the Southeast; 🇺🇸 West Palm Beach, Florida, United States

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.; 🇺🇸 San Diego, California, United States

Nashville Centre for Laser and Facial Surgery; 🇺🇸 Nashville, Tennessee, United States

DeNova Research; 🇺🇸 Chicago, Illinois, United States