- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846039
JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose
April 3, 2019 updated by: Allergan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia
-
-
Queensland
-
Gold Coast, Queensland, Australia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- -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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JUVÉDERM VOLUMA®
Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
|
Up to 3 mL administered by intradermal injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Day 113
|
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.
|
Baseline, Day 113
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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
|
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
|
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.
|
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
|
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.
|
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
|
Days 113, 239 and 421
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
August 5, 2014
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VOLXC-AP-ND-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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