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

Phase 3

Completed

Conditions: Temple Hollowing

Interventions: Device: JUVÉDERM® VOLUMA® with Lidocaine

Registration Number: NCT04891419

Lead Sponsor: Allergan

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 168

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 14 Months	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
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)	Change from Baseline to Month 6	The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6	Change from Baseline to Month 6	Participant-assessed satisfaction using the 12-item FACE-Q Satisfaction with Temples Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6	Change from baseline to Month 6	Participant-assessed satisfaction using the 10-item FACE-Q Satisfaction with Facial Appearance Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)	Month 6	Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)	Month 6	The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.

Trial Locations

Locations (8): China-Japan Friendship Hospital /ID# 241680
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Beijing, Beijing, China
Beijing Hospital /ID# 233582
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Beijing, Beijing, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602
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Wuhan, Hubei, China
Nanjing Drum Tower Hospital /ID# 233607
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Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 233604
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Nanjing, Jiangsu, China
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 233571
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Shanghai, Shanghai, China
Shanghai Sixth People's Hospital /ID# 233568
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Shanghai, Shanghai, China
Peking University International Hospital /ID# 242166
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Beijing, China