Asian Nose EnhancementNCT01846039
JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose
A study testing Crosslinked hyaluronic acid gel in people with Asian Nose Enhancement, run by Allergan at 2 sites in Australia.
Trial summary
A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asian Nose Enhancement
- What is being tested?
- Crosslinked hyaluronic acid gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Apr 2013to 5 Aug 2014
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asian subjects aged 20 years of age or older with dissatisfaction of their aesthetic appearance due to structural features of their nose
- Subjects who, in the opinion of the Investigator, can achieve a clinically meaningful aesthetic correction of their nose with VOLUMA® treatment
Who cannot join
- -Subjects requiring filler treatment in or around the tip of the nose or between the eyebrows (glabellar region) to achieve a good aesthetic outcome
- prior nasal surgery, including grafts, implants or filler injection to the nose area
- Subjects with a history of sinusitis or rhinitis
- Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product.
- Subjects receiving botulinum toxin treatment for any indication within 3 months of the study or planning to receive botulinum toxin during the study
- Subjects who have previously received aesthetic treatment in the forehead, glabellar, and/or nose area with any dermal filler
Show all 20Show fewer
- Subjects with a history of any significant adverse events caused by dermal fillers
- Subjects with a history of allergic responses to lidocaine or fillers
- Subjects who are pregnant or breastfeeding or wish to become pregnant during the study
- Subjects of child-bearing age who are not prepared to practice an adequate form of contraception during the course of the study
- Subjects with traumatic scars in the treatment area or a history of active inflammation, infection, cancerous lesion, or an unhealed wound in the treatment area
- Subjects requiring dental or oral surgery, including dental implants, during the study period
- Subjects with a history of bleeding disorders
- Subjects who are smokers
- Subjects using blood thinning products within 10 days of the screening visit
- Subjects with a history of connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma, etc) causing skin scarring
- Subjects with a history of untreated epilepsy or other significant medical conditions
- Subjects with a history of alcoholism or drug abuse of dependence
- Subjects participating or likely to participate in another clinical trial within 30 days of screening or during the 1 year period of the study
- Subjects with any other medical condition, which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Study site
Gold Coast, Queensland
Study site
Sydney, New South Wales
About this study
Official title: A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose
A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose.
- Conditions
- Asian Nose Enhancement
- Being tested
- Crosslinked hyaluronic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crosslinked hyaluronic acid gelDevice
Also called JUVÉDERM VOLUMA®
Up to 3 mL administered by intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM VOLUMA® | Experimental | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. Receives: Device: Crosslinked hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113
The independent central evaluating physician evaluated the improvement of the participant's nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.
Measured: Baseline, Day 113
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113
The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.
Measured: Baseline, Day 113
Secondary outcomes (5)
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician
The independent central evaluating physician evaluated the improvement of the participant's nose compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.
Measured: Baseline, Days 239 and 421
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient
The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported
Measured: Baseline, Days 239 and 421
Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)
Participants assessed their satisfaction with the appearance of their nose at Days 113, 239 and 421 using the NSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants who rated themselves as satisfied or very satisfied is reported.
Measured: Days 113, 239 and 421
Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)
Participants assessed their satisfaction with the study drug (VOLUMA) treatment at Days 113, 239 and 421 using the TSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants satisfied or very satisfied with study drug treatment is reported.
Measured: Days 113, 239 and 421
Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others
Measured: Days 113, 239 and 421
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start1 Apr 2013
- Primary completion1 Sep 2013
- Study completion5 Aug 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asian 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846039
- Sponsor's protocol ID
- VOLXC-AP-ND-001
- Status last verified
- Apr 2019
- First submitted
- 1 May 2013
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Liew S, Scamp T, de Maio M, Halstead M, Johnston N, Silberberg M, Rogers JD. Efficacy and Safety of a Hyaluronic Acid Filler to Correct Aesthetically Detracting or Deficient Features of the Asian Nose: A Prospective, Open-Label, Long-Term Study. Aesthet Surg J. 2016 Jul;36(7):760-72. doi: 10.1093/asj/sjw079. Epub 2016 Jun 14.
PubMed 27301371
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose
- ClinicalTrials.gov ID
- NCT01846039
- Acronym / sponsor ID
- VOLXC-AP-ND-001
- Conditions
- Asian Nose Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Sep 2013 (actual)
- Study completion
- 5 Aug 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 9 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM VOLUMA® | Experimental | Device: Crosslinked hyaluronic acid gelParticipants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asian subjects aged 20 years of age or older with dissatisfaction of their aesthetic appearance due to structural features of their nose
- Subjects who, in the opinion of the Investigator, can achieve a clinically meaningful aesthetic correction of their nose with VOLUMA® treatment
Key exclusion criteria (20 listed)
- -Subjects requiring filler treatment in or around the tip of the nose or between the eyebrows (glabellar region) to achieve a good aesthetic outcome
- prior nasal surgery, including grafts, implants or filler injection to the nose area
- Subjects with a history of sinusitis or rhinitis
- Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product.
- Subjects receiving botulinum toxin treatment for any indication within 3 months of the study or planning to receive botulinum toxin during the study
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 |
|---|---|---|
| Crosslinked hyaluronic acid gelAlso: JUVÉDERM VOLUMA®Up to 3 mL administered by intradermal injection | Device | JUVÉDERM VOLUMA® |
Primary outcome
Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113
Time frame: Baseline, Day 113
The independent central evaluating physician evaluated the improvement of the participant's nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113
Time frame: Baseline, Day 113
The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.
5 secondary outcomes
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician
Time frame: Baseline, Days 239 and 421
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient
Time frame: Baseline, Days 239 and 421
Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)
Time frame: Days 113, 239 and 421
Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)
Time frame: Days 113, 239 and 421
Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others
Time frame: Days 113, 239 and 421
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27301371Liew S, Scamp T, de Maio M, Halstead M, Johnston N, Silberberg M, Rogers JD. Efficacy and Safety of a Hyaluronic Acid Filler to Correct Aesthetically Detracting or Deficient Features of the Asian Nose: A Prospective, Open-Label, Long-Term Study. Aesthet Surg J. 2016 Jul;36(7):760-72. doi: 10.1093/asj/sjw079. Epub 2016 Jun 14.
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.
Medical Director study director
Allergan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crosslinked hyaluronic acid gel in people with Asian Nose Enhancement, run by Allergan at 2 sites in Australia.
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 2 inclusion and 20 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 9 Oct 2015). 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?
Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113 (time frame: Baseline, Day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01846039, which also lists 1 linked publication.
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 16 Apr 2019.