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

Allergan

Status: Terminated

Conditions: Temple Hollowing

Treatments: Device: Juvéderm® VOLUMA XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03166618

VOLUMA-007

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

VOLUMA® XC Treatment

Experimental group

Description:

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.

Treatment:

Device: Juvéderm® VOLUMA XC

Control_No Treatment

No Intervention group

Description:

No treatment is administered.