Clinical trial NCT04891419: JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
Official title: A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Temple Hollowing
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 14 Months
measure: Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS)
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6
timeFrame: Change from Baseline to Month 6
measure: Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6
timeFrame: Change from baseline to Month 6
measure: Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 6
measure: Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital /ID# 241680
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital /ID# 233582
state: Beijing
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 233607
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 233604
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 233571
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital /ID# 233568
state: Shanghai
city: Beijing
country: China
facility: Peking University International Hospital /ID# 242166
Study officials:
affiliation: Allergan
name: ALLERGAN, INC.
role: STUDY_DIRECTOR
References: