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

Chin Retrusion Clinical Trial

Official title:

A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833077
• Other study ID #: Voluma-006
• Status: Completed
• Phase: N/A
• Start date: June 28, 2016
• Est. completion date: October 11, 2018

Study information

• Verified date: July 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: October 11, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chin Retrusion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Dermatology & Laser Center of Charleston Center for Clinical Research	Charleston	South Carolina
United States	SkinCare Physicians of Chestnut Hill	Chestnut Hill	Massachusetts
United States	DeNova Research	Chicago	Illinois
United States	Skin Research Institute	Coral Gables	Florida
United States	Callender Dermatology and Cosmetic Center	Glenn Dale	Maryland
United States	Williams Plastic Surgery Specialists	Latham	New York
United States	Baumann Cosmetic and Res. Institute	Miami Beach	Florida
United States	Image Dermatology, PC	Montclair	New Jersey
United States	The Center for Dermatology, Cosmetics, & Laser Surgery	Mount Kisco	New York
United States	Nashville Centre for Laser and Facial Surgery	Nashville	Tennessee
United States	St Louis University Medical Center Dept. of Dermatology	Saint Louis	Missouri
United States	Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.	San Diego	California
United States	Premier Clinical Research; Spokane Dermatology Clinic	Spokane	Washington
United States	Research Institute of the Southeast	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

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

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