A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

Allergan

Status and phase: Completed; Phase 3

Conditions: Temple Hollowing

Treatments: Device: JUVÉDERM® VOLUMA® XC; Other: No-treatment control

Study type: Interventional

Funder types: Industry

Identifiers

NCT04414397

1878-702-008

Details and patient eligibility

About

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

Enrollment: 205 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Temple hollowing due to trauma, congenital malformations, or lipodystrophy
• Temporomandibular joint dysfunction or any other jaw issues
• Recurrent temporal headaches such as temporal tendinitis migraine
• Active autoimmune disease
• History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
• 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
• Botulinum toxin treatment above the subnasale within 6 months before enrollment
• Females who are pregnant, nursing, or planning a pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 2 patient groups

No Treatment then JUVÉDERM® VOLUMA® XC

Other group

Description:

Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.

Treatment:

Other: No-treatment control

Device: JUVÉDERM® VOLUMA® XC

JUVÉDERM® VOLUMA® XC

Experimental group

Description:

Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.

Treatment:

Device: JUVÉDERM® VOLUMA® XC