A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
1 other identifier
interventional
221
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2016
CompletedFirst Submitted
Initial submission to the registry
July 12, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2018
CompletedResults Posted
Study results publicly available
July 23, 2020
CompletedJuly 23, 2020
July 1, 2020
1.6 years
July 12, 2016
July 10, 2020
July 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline (up to 30 days prior to randomization) to Month 6
Secondary Outcomes (3)
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
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
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
Study Arms (2)
JUVÉDERM VOLUMA® XC
EXPERIMENTALJUVÉDERM 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.
No Treatment then JUVÉDERM VOLUMA® XC
OTHERNo 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.
Interventions
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 Criteria
You may qualify if:
- Chin retrusion
- In good general health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (14)
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121, United States
Skin Research Institute
Coral Gables, Florida, 33146, United States
Baumann Cosmetic and Res. Institute
Miami Beach, Florida, 33137, United States
Research Institute of the Southeast
West Palm Beach, Florida, 33401, United States
DeNova Research
Chicago, Illinois, 60611, United States
Callender Dermatology and Cosmetic Center
Glenn Dale, Maryland, 20769, United States
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 01467, United States
St Louis University Medical Center Dept. of Dermatology
St Louis, Missouri, 63104, United States
Image Dermatology, PC
Montclair, New Jersey, 07042, United States
Williams Plastic Surgery Specialists
Latham, New York, 12110, United States
The Center for Dermatology, Cosmetics, & Laser Surgery
Mount Kisco, New York, 10549, United States
Dermatology & Laser Center of Charleston Center for Clinical Research
Charleston, South Carolina, 29414, United States
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, 37203, United States
Premier Clinical Research; Spokane Dermatology Clinic
Spokane, Washington, 99202, United States
Related Publications (1)
Beer K, Kaufman-Janette J, Bank D, Biesman B, Dayan S, Kim W, Chawla S, Schumacher A. Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L. Dermatol Surg. 2021 Jan 1;47(1):80-85. doi: 10.1097/DSS.0000000000002795.
PMID: 33347003DERIVED
Related Links
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Andrew Schumacher
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2016
First Posted
July 14, 2016
Study Start
June 28, 2016
Primary Completion
February 6, 2018
Study Completion
October 11, 2018
Last Updated
July 23, 2020
Results First Posted
July 23, 2020
Record last verified: 2020-07