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

Not Applicable

Terminated

Conditions: Temple Hollowing

Interventions: Device: Juvéderm® VOLUMA XC

Registration Number: NCT03166618

Lead Sponsor: Allergan

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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VOLUMA® XC Treatment	Juvéderm® VOLUMA XC	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.

Primary Outcome Measures

Name	Time	Method
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)	Change from Baseline to Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)	Month 3	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.
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS	Month 3	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.