JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JUVÉDERM® VOLUMA® with Lidocaine Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment |
Device: JUVÉDERM® VOLUMA® with Lidocaine
JUVÉDERM® VOLUMA® with Lidocaine injectable gel
|
| No Intervention: Control- No treatment No treatment is administered. Optional treatment at month 6. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 6 [Change from baseline to 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 on FACE-Q Satisfaction with Temples questionnaire at Month 6 [Change from Baseline to 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must be 18 or over, at the time of signing the ICF
-
Participants seeking improvement of temple hollowing
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Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
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Written informed consent from the participant has been obtained prior to any study-related procedures
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Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
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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:
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Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired
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Has experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring
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Temporal arteritis or history of temporal arteritis
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Temporomandibular joint dysfunction or any other jaw issues
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Recurrent temporal headaches such as temporal tendinitis migraine
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Active or recurrent inflammation or infection in either eye
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Tendency to develop hypertrophic scarring
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Active autoimmune disease
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History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
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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
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Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
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Fat injection or permanent facial implants anywhere in the face
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Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
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Temporary dermal filler injections above the subnasale within 12 months before enrollment
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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.
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Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment
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Botulinum toxin treatment above the subnasale within 6 months before enrollment
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Has braces or other orthodontics
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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
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Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
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Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple
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Females who are pregnant, nursing, or planning a pregnancy
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Plans a significant weight change (more than 10% of body weight) during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Hospital /ID# 233582 | Beijing | Beijing | China | 100730 |
| 2 | Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602 | Wuhan | Hubei | China | 430022 |
| 3 | Nanjing Drum Tower Hospital /ID# 233607 | Nanjing | Jiangsu | China | 210008 |
| 4 | Zhongda Hospital Southeast University /ID# 233604 | Nanjing | Jiangsu | China | 210009 |
| 5 | Shanghai Sixth People's Hospital /ID# 233568 | Shanghai | Shanghai | China | 200233 |
| 6 | China-Japan Friendship Hosp /ID# 241680 | Beijing | China | 100029 | |
| 7 | Peking University International Hospital /ID# 242166 | Beijing | China | 102206 | |
| 8 | Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 233571 | Shanghai | China | 200011 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: ALLERGAN INC., Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1878-701-008