Overview

The objectives of this study are to evaluate the safety and effectiveness of Juvederm Voluma XC injectable gel in adult participants seeking correction of temple hollowing

Eligibility

Inclusion Criteria:

• Participants in general good health
• Participants seeking improvement of temple hollowing

Exclusion Criteria:

• Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired
• Experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring
• Temporal arteritis or history of temporal arteritis
• Temporomandibular joint dysfunction or any other jaw issues
• Recurrent temporal headaches such as temporal tendinitis migraine
• Active or recurrent inflammation or infection in either eye
• Tendency to develop hypertrophic scarring
• Active autoimmune disease
• History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
• Current cutaneous or mucosal inflammatory or infectious processes (e.g. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, above the subnasal
• History of detached retina, retinal vascular occlusion (eg, vein or arterial occlusion), narrow angle glaucoma, neovascular eye disease, or severely impaired/absent eye function in 1 or both eyes
• Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
• Fat injection or permanent facial implants anywhere in the face
• Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
• Temporary dermal filler injections above the subnasale within 24 months before enrollment
• Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment (examples of mesotherapy or cosmetic facial procedures are face-lift, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures
• Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment
• Botulinum toxin treatment above the subnasale within 6 months before enrollment
• Has braces or other orthodontics or is planning such treatment during the study
• Not eligible for this study if participants have begun using any new over the counter or prescription oral or tropical, anti-wrinkle products above the subnasale within 30 days before enrollment or are planning to begin using such products during the study. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study
• Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
• Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple
• Females who are pregnant, nursing, or planning a pregnancy
• Plans a significant weight change (more than 10% of body weight) during the study