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

Launched by ALLERGAN · May 14, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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