Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

A Multicenter, Single-Blind, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.

Study Overview

• Status: Terminated
• Conditions: Temple Hollowing
• Intervention / Treatment: Device: Juvéderm® VOLUMA XC

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90069
      • Skin Care and Laser Physicians of Beverly Hills

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Has temple hollowing and is seeking restoration in the temple area.

Exclusion Criteria:

• Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy
• Has received permanent facial implants in the face or neck
• Has undergone fat injections
• Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple
• Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months
• Has undergone dermal filler injections above the subnasale within the past 24 months
• Has temporal arteritis or history of temporal arteritis
• Has temporomandibular joint dysfunction
• Has eye inflammation or infection
• Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease
• Has ever received a facelift, browlift, or facial reconstructive surgery
• Has undergone mesotherapy or cosmetic treatment (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 or botulinum toxin injections within the past 6 months
• Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring
• Has a tendency to develop hypertrophic scarring
• Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
• Has porphyria or untreated epilepsy
• Has active autoimmune disease
• Has current cutaneous or mucosal inflammatory or infectious processes
• Is on a lidocaine, anticoagulation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VOLUMA® XC Treatment; Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.	Device: Juvéderm® VOLUMA XC; Juvéderm® VOLUMA XC hyaluronic acid injectable gel
No Intervention: Control_No Treatment; No treatment is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)	The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.	Change from Baseline to Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)	The Evaluating Investigator will assess the participant's temple 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 3
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS	The participant will assess their temple 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 3

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Nikki Amaratunge, Allergan

Publications and helpful links

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): July 21, 2017

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: VOLUMA-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes