Safety and Effectiveness of JUVÉDERM® V… | Clinical Trial

Key information

Conditions

Nose Enhancement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JUVÉDERM® VOLUMA® with Lidocaine

Device

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

No-treatment control

Other

No treatment during the control period.

Primary outcomes

Volume Change From Baseline in the Nose Area

Time frame: 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 outcomes

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

Time frame: 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.
Percentage of Participants Who Noted "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS in the Treatment Group

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

Time frame: 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Randomized, Multicenter, "No-Treatment" Control Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine Injectable Gel for the Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 13, 2018
Registry last updated: Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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