Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults
NCT ID: NCT03430986
Last Updated: 2020-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2018-02-02
2019-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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JUVÉDERM® VOLUMA® with Lidocaine
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
JUVÉDERM® VOLUMA® with Lidocaine
Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later.
No-treatment Control
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine Injectable Gel in the nose area during the 24-week Post-Control period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
JUVÉDERM® VOLUMA® with Lidocaine
Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later.
No-treatment control
No treatment during the control period.
Interventions
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JUVÉDERM® VOLUMA® with Lidocaine
Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later.
No-treatment control
No treatment during the control period.
Eligibility Criteria
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Inclusion Criteria
* Requires a total volume of at least 0.5 mL but not exceeding 3.0 mL of VOLUMA with Lidocaine for initial and touch-up treatment combined, and treatment to the nasal dorsum is mandatory to achieve an aesthetic improvement in the subject's nose appearance, in the Treating Investigator (TI's) opinion
* Has a reasonable treatment goal for aesthetic improvement in nose, in the TI's opinion. Participant and TI have aligned the treatment goals.
Exclusion Criteria
* Has active autoimmune disease
* Is on a concurrent regimen of lidocaine or structurally-related local anesthetics (eg, bupivacaine)
* Is on an ongoing regimen of anti-coagulation therapy (eg, warfarin)
* Within 10 days of undergoing study device injection, is on an ongoing regimen of medications (eg, aspirin or ibuprofen) or other substances (eg, high doses of Vitamin C or Vitamin E or herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time, or is currently menstruating (study treatment may be delayed as necessary to accommodate menstrual period cessation and/or anticoagulation washout interval)
* Has participated in any clinical trials within 4 weeks prior to signing the informed consent form (ICF) or is planning to participate in another clinical trial during the course of this study
* Females who are pregnant, nursing, or planning a pregnancy during the course of the study. Females of childbearing potential who have a positive pregnancy test result during screening. Females who intend to breastfeed during the study. Females of childbearing potential who are unwilling to use birth control measures during the full course of the study. Birth control measures include oral contraceptives (stable) use for 2 or more cycles prior to screening), intrauterine devices, hormonal injections, hormonal implants, bilateral tube ligation, vasectomy, condom or diaphragm plus either contraceptive sponge, foam, or jelly
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Lijuan Zhang
Role: STUDY_DIRECTOR
Allergan
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Beijing, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Beijing, Wuhan, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1894-701-008
Identifier Type: -
Identifier Source: org_study_id