Nose Enhancement
Conditions
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.
Interventions
Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later.
OTHERNo-treatment control
No treatment during the control period.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| 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. | 120 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 24-week Control Period | Adverse Event | 1 | 0 |
| 24-week Control Period | Lost to Follow-up | 2 | 2 |
| 24-week Control Period | Protocol Deviation | 0 | 2 |
| 24-week Control Period | Withdrawal by Participant | 5 | 0 |
| 24-week Post-Control Period | Lost to Follow-up | 1 | 1 |
| 24-week Post-Control Period | Withdrawal by Participant | 0 | 1 |
Baseline characteristics
| Characteristic | No-treatment Control | JUVÉDERM® VOLUMA® With Lidocaine | Total |
|---|---|---|---|
| Age, Continuous | 28.9 years STANDARD_DEVIATION 5.95 | 32.0 years STANDARD_DEVIATION 10.42 | 31.3 years STANDARD_DEVIATION 9.63 |
| Race/Ethnicity, Customized Ethnicity Chinese | 37 Participants | 120 Participants | 157 Participants |
| Race/Ethnicity, Customized Race Asian | 37 Participants | 120 Participants | 157 Participants |
| Region of Enrollment China | 37 Participants | 120 Participants | 157 Participants |
| Sex: Female, Male Female | 35 Participants | 112 Participants | 147 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 122 | 0 / 118 | 0 / 31 |
| other Total, other adverse events | 12 / 37 | 20 / 120 | 23 / 118 | 10 / 31 |
| serious Total, serious adverse events | 1 / 37 | 0 / 120 | 2 / 118 | 1 / 31 |
Outcome results
Primary
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.
Time frame: Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24
Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group) and participants who are randomized to no treatment and complete at least 1 effectiveness assessment (control group).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| No-treatment Control | Volume Change From Baseline in the Nose Area | -0.005 cubic centimeters (cc) | Standard Error 0.1381 |
| JUVÉDERM® VOLUMA® With Lidocaine | Volume Change From Baseline in the Nose Area | 2.032 cubic centimeters (cc) | Standard Error 0.0764 |
p-value: <0.000195% CI: [1.726, 2.349]MMRM
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period
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.
Time frame: 24 Weeks
Population: Safety Population included all randomized participants who received VOLUMA treatment in the Control Period (CP) or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No-treatment Control | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period | 17 Participants |
| JUVÉDERM® VOLUMA® With Lidocaine | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period | 43 Participants |
Secondary
Percentage of Participants Where the Evaluating Investigator Noted Improved or Much Improved Using the Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: Week 24
Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group) and participants who are randomized to no treatment and complete at least 1 effectiveness assessment (control group). Participants analyzed are the number of participants with available data at the given timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No-treatment Control | Percentage of Participants Where the Evaluating Investigator Noted Improved or Much Improved Using the Global Aesthetic Improvement Scale (GAIS) | 18.8 percentage of participants |
| JUVÉDERM® VOLUMA® With Lidocaine | Percentage of Participants Where the Evaluating Investigator Noted Improved or Much Improved Using the Global Aesthetic Improvement Scale (GAIS) | 87.2 percentage of participants |
p-value: <0.000195% CI: [50, 82.4]Fisher Exact
Secondary
Percentage of Participants Who Noted Improved or Much Improved as Assessed by the Participant Using the GAIS in the Treatment Group
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.
Time frame: Week 24
Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group). Participants analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No-treatment Control | Percentage of Participants Who Noted Improved or Much Improved as Assessed by the Participant Using the GAIS in the Treatment Group | 91.5 percentage of participants |
Secondary
Percentage of Participants Who Noted Satisfied or Very Satisfied With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group
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.
Time frame: Week 24
Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group). Participants analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No-treatment Control | Percentage of Participants Who Noted Satisfied or Very Satisfied With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group | 95.7 percentage of participants |