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

NCT03430986 | Completed Results

• 1 other identifier: 1894-701-008
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 5

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.

Conditions

Nose Enhancement

Outcome Measures

Primary Outcomes (1)

• Volume Change From Baseline in the Nose Area

  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.

  Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24

Secondary Outcomes (4)

• Percentage of Participants Where the Evaluating Investigator Noted "Improved" or "Much Improved Using the Global Aesthetic Improvement Scale (GAIS)

  Week 24

• Percentage of Participants Who Noted "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS in the Treatment Group

  Week 24

• Percentage of Participants Who Noted "Satisfied" or "Very Satisfied" With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group

  Week 24

• Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period

  24 Weeks

Study Arms (2)

JUVÉDERM® VOLUMA® with Lidocaine

EXPERIMENTAL

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.

Device: JUVÉDERM® VOLUMA® with Lidocaine

No-treatment Control

EXPERIMENTAL

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.

Device: JUVÉDERM® VOLUMA® with Lidocaine; Other: No-treatment control

Interventions

JUVÉDERM® VOLUMA® with Lidocaine DEVICE

Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later.

JUVÉDERM® VOLUMA® with Lidocaine; No-treatment Control

No-treatment control OTHER

No treatment during the control period.

No-treatment Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (5)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Beijing, Shanghai Municipality, 200011, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Beijing, Wuhan, 430002, China

Location

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Lijuan Zhang

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 13, 2018
• Study Start: February 2, 2018
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: December 30, 2020
• Results First Posted: December 30, 2020

Record last verified: 2020-12

Locations

CN (5)