Nose EnhancementNCT03430986
Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults
A study testing JUVÉDERM® VOLUMA® with Lidocaine in people with Nose Enhancement, run by Allergan at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nose Enhancement
- What is being tested?
- JUVÉDERM® VOLUMA® with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 5 sitesChina
- Study dates
- 2 Feb 2018to 4 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Beijing, Shanghai Municipality, 200011
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Beijing, Wuhan, 430002
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official 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
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
- Being tested
- JUVÉDERM® VOLUMA® with Lidocaine, No-treatment control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM® VOLUMA® with LidocaineDevice
Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later.
No-treatment controlOther
No treatment during the control period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: JUVÉDERM® VOLUMA® with Lidocaine; Other: No-treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Week 24
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.
Measured: Week 24
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.
Measured: Week 24
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.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start2 Feb 2018
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nose EnhancementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lijuan Zhang, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430986
- Sponsor's protocol ID
- 1894-701-008
- Status last verified
- Dec 2020
- First submitted
- 2 Feb 2018
- Last updated
- 30 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03430986
- Acronym / sponsor ID
- 1894-701-008
- Conditions
- Nose Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Posted 30 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM® VOLUMA® with Lidocaine | Experimental | Device: JUVÉDERM® VOLUMA® with LidocaineParticipants 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 | Experimental | Device: JUVÉDERM® VOLUMA® with Lidocaine, Other: No-treatment controlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUVÉDERM® VOLUMA® with LidocaineTreatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later. | Device | JUVÉDERM® VOLUMA® with Lidocaine, No-treatment Control |
| No-treatment controlNo treatment during the control period. | Other | No-treatment Control |
Primary outcome
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.
4 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
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
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
Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijuan Zhang study director
Allergan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUVÉDERM® VOLUMA® with Lidocaine in people with Nose Enhancement, run by Allergan at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.