Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

Jawline Definition Clinical Trial

Official title:

A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712137
• Other study ID #: V25L-002
• Status: Completed
• Phase: Phase 3
• Start date: November 12, 2018
• Est. completion date: January 26, 2021

Study information

• Verified date: September 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 26, 2021
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3
• Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition
• Written Informed Consent (IC) has been obtained

Exclusion Criteria:

• Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
• Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study
• Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study
• Has received deoxycholic acid treatment in the submental region in the last 6 months
• Has active autoimmune disease
• Females who are pregnant, nursing, or planning a pregnancy during the course of the study

Related Conditions & MeSH terms

• Jawline Definition

Intervention

Device:
• VOLUX XC
Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.

Other:
• No-treatment control
No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.

Locations

Country	Name	City	State
United States	SkinDC	Arlington	Virginia
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Susan H Weinkle, MD	Bradenton	Florida
United States	Aesthetic Solutions, PA.	Chapel Hill	North Carolina
United States	DeNova Research dba Arano, LLC	Chicago	Illinois
United States	Hevia Cosmetic Dermatology	Coral Gables	Florida
United States	Skin Research Institute LLC	Coral Gables	Florida
United States	Callender Center for Clinical Research	Glenn Dale	Maryland
United States	Suzanne Bruce and Associates, P.A., The Center for Skin Research	Houston	Texas
United States	MDLSV	Hunt Valley	Maryland
United States	Williams Center	Latham	New York
United States	Westside Aesthetics	Los Angeles	California
United States	Baumann Cosmetic and Research Institute	Miami	Florida
United States	The Center for Dermatology, Cosmetic & Laser Surgery	Mount Kisco	New York
United States	Center aesthetic and dermatology	New York	New York
United States	Laser & Skin Surgery Center of New York	New York	New York
United States	Artemedica	Santa Rosa	California
United States	Center for Dermatology and Dermatologic Surgery	Washington	District of Columbia

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 Who Show = 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)	The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)	Month 6
Secondary	Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)	The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.	Month 6
Secondary	Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)	The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.	Month 6
Secondary	Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score	The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best)	Baseline to Month 6