A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
NCT ID: NCT02833077
Last Updated: 2020-07-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
221 participants
INTERVENTIONAL
2016-06-28
2018-10-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
NCT03712137
Juvederm Voluma® XC for the Treatment of Hypoplastic Chin
NCT02330016
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
NCT00978042
A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
NCT04414397
JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness
NCT03728309
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
JUVÉDERM VOLUMA® XC
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.
No Treatment then 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 was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JUVÉDERM VOLUMA® XC
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* In good general health
Exclusion Criteria
* 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
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Schumacher
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
St Louis, Missouri, United States
Image Dermatology, PC
Montclair, New Jersey, United States
Williams Plastic Surgery Specialists
Latham, New York, United States
The Center for Dermatology, Cosmetics, & Laser Surgery
Mount Kisco, New York, United States
Dermatology & Laser Center of Charleston Center for Clinical Research
Charleston, South Carolina, United States
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States
Premier Clinical Research; Spokane Dermatology Clinic
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
More Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Voluma-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.