Status:
COMPLETED
JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
Lead Sponsor:
Allergan
Conditions:
Temple Hollowing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2023
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04891419
Start Date
July 20 2021
End Date
November 22 2023
Last Update
December 12 2024
Active Locations (8)
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1
China-Japan Friendship Hospital /ID# 241680
Beijing, Beijing Municipality, China, 100029
2
Beijing Hospital /ID# 233582
Beijing, Beijing Municipality, China, 100730
3
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602
Wuhan, Hubei, China, 430022
4
Nanjing Drum Tower Hospital /ID# 233607
Nanjing, Jiangsu, China, 210008