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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04891419
Other study ID # 1878-701-008
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 20, 2021
Est. completion date November 22, 2023

Study information

Verified date December 2023
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date November 22, 2023
Est. primary completion date November 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
JUVÉDERM® VOLUMA® with Lidocaine
JUVÉDERM® VOLUMA® with Lidocaine injectable gel

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. Up to 14 Months
Primary 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) 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. Change from Baseline to Month 6
Secondary Change from baseline on FACE-Q Satisfaction with Temples questionnaire at Month 6 16-item questionnaire assessing satisfaction with various aspects of facial appearance. Participants respond to each item as: 1 Very Dissatisfied, 2 Somewhat Dissatisfied, 3 Somewhat Satisfied, 4 Very Satisfied. Change from Baseline to Month 6
Secondary Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 6 10-item questionnaire assessing satisfaction with various aspects of facial appearance. Participants respond to each item as: 1 Very Dissatisfied, 2 Somewhat Dissatisfied, 3 Somewhat Satisfied, 4 Very Satisfied. Change from baseline to Month 6
Secondary Participants "Improved" or "Much Improved" as self-assessed by participant using the Global Aesthetic Improvement Scale (GAIS) 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. Month 6
Secondary Participants "Improved" or "Much Improved" as assessed by the Evaluating Investigator using the Global Aesthetic Improvement Scale (GAIS) 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. Month 6
See also
  Status Clinical Trial Phase
Completed NCT04414397 - A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old Phase 3
Terminated NCT03166618 - Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing N/A