Clinical trial NCT02833077: A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
Official title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Retrusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 221
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
timeFrame: Baseline (up to 30 days prior to randomization) to Month 6
Secondary outcomes:
measure: Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire
timeFrame: Baseline (up to 30 days prior to randomization) to Month 6
measure: 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
timeFrame: Baseline (up to 30 days prior to randomization) to Month 6
measure: Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants
timeFrame: Baseline (up to 30 days prior to randomization) to Month 6
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Miami Beach
country: United States
facility: Baumann Cosmetic and Res. Institute
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast
state: Florida
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Glenn Dale
country: United States
facility: Callender Dermatology and Cosmetic Center
state: Maryland
city: Chestnut Hill
country: United States
facility: SkinCare Physicians of Chestnut Hill
state: Massachusetts
city: Saint Louis
country: United States
facility: St Louis University Medical Center Dept. of Dermatology
state: Missouri
city: Montclair
country: United States
facility: Image Dermatology, PC
state: New Jersey
city: Latham
country: United States
facility: Williams Plastic Surgery Specialists
state: New York
city: Mount Kisco
country: United States
facility: The Center for Dermatology, Cosmetics, & Laser Surgery
state: New York
city: Charleston
country: United States
facility: Dermatology & Laser Center of Charleston Center for Clinical Research
state: South Carolina
city: Nashville
country: United States
facility: Nashville Centre for Laser and Facial Surgery
state: Tennessee
city: Spokane
country: United States
facility: Premier Clinical Research; Spokane Dermatology Clinic
state: Washington
Study officials:
affiliation: Allergan
name: Andrew Schumacher
role: STUDY_DIRECTOR
References:
citation: 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.