Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults

Not Applicable

Completed

• Conditions: Nose Enhancement
• Interventions: Device: JUVÉDERM® VOLUMA® with Lidocaine; Other: No-treatment control

• Registration Number: NCT03430986
• Lead Sponsor: Allergan

Brief Summary

The purpose of this study is to determine whether VOLUMA with Lidocaine is safe and effective for the improvement of volume and aesthetic appearance of the nose in the Chinese population.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-13
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Status Verified: 2020-12
• Results First Submitted: 2020-12-04
• Results First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-04
• Results First Posted: 2020-12-30
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Is not satisfied with his/her aesthetic appearance due to structural features of his/her nose and assessed as either "dissatisfied" or "very dissatisfied" by using the 5-point Nose Satisfaction Scale (NSS)
• 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 a small, shallow nose such that the volume of filler implant needed to create the desired dorsal height is in excess of the ability of the skin and soft tissue to expand and accommodate the implant
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JUVÉDERM® VOLUMA® with Lidocaine	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.
No-treatment Control	JUVÉDERM® VOLUMA® with Lidocaine	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.
No-treatment Control	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.

Primary Outcome Measures

Name	Time	Method
Volume Change From Baseline in the Nose Area	Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24	Volume of the nose was calculated by digital analysis of each participant's 3-dimensional (3D) images. A mixed-effects model for repeated measures (MMRM) was used for analysis. A positive change from Baseline indicates improvement. An analysis model was created by Canfield Scientific, only volume changes are available. Actual Baseline values are not available.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Where the Evaluating Investigator Noted "Improved" or "Much Improved Using the Global Aesthetic Improvement Scale (GAIS)	Week 24	The Evaluating Investigator assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assessed as 2=much improved or 1=improved is reported.
Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period	24 Weeks	An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Percentage of Participants Who Noted "Satisfied" or "Very Satisfied" With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group	Week 24	The participant used the 5-point NSS to assess the treatment outcome of the nose where: +2=very satisfied, +1=satisfied, 0=neutral (neither satisfied or dissatisfied), -1=dissatisfied and -2= very dissatisfied. The percentage of participants who assessed themselves as +2=Very Satisfied or +1=Satisfied is reported.
Percentage of Participants Who Noted "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS in the Treatment Group	Week 24	The participant assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved is reported.

Trial Locations

Locations (5)

Union Hospital Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Beijing, Wuhan, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Beijing, Shanghai, China