JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population

Allergan

Status and phase: Completed; Phase 3

Conditions: Temple Hollowing

Treatments: Device: JUVÉDERM® VOLUMA® with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04891419

1878-701-008

Details and patient eligibility

About

The objectives of this study are to evaluate the safety and effectiveness of JUVÉDERM® VOLUMA® with Lidocaine injectable gel in adult Chinese population seeking correction of temple hollowing.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be 18 or over, at the time of signing the ICF
• Participants seeking improvement of temple hollowing
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
• Written informed consent from the participant has been obtained prior to any study-related procedures
• Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
• Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all participant self-assessments)

Exclusion criteria

• Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired
• Has 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
• 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 12 months before enrollment
• Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment (examples of mesotherapy or cosmetic facial procedures are 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
• 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. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

JUVÉDERM® VOLUMA® with Lidocaine

Experimental group

Description:

Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment

Treatment:

Device: JUVÉDERM® VOLUMA® with Lidocaine

Control- No treatment

No Intervention group

Description:

No treatment is administered. Optional treatment at month 6.