JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose
Study Details
Study Description
Brief Summary
A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: JUVÉDERM VOLUMA® Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Device: Crosslinked hyaluronic acid gel
Up to 3 mL administered by intradermal injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [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 [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.
Secondary Outcome Measures
- Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician [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.
- Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient [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
- Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS) [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.
- Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS) [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.
- Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others [Days 113, 239 and 421]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sydney | New South Wales | Australia | ||
2 | Gold Coast | Queensland | Australia |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
- VOLXC-AP-ND-001
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Period Title: Overall Study | |
STARTED | 29 |
COMPLETED | 27 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Overall Participants | 29 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
40.2
(11.78)
|
Sex: Female, Male (Count of Participants) | |
Female |
26
89.7%
|
Male |
3
10.3%
|
Outcome Measures
Title | 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 |
---|---|
Description | 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. |
Time Frame | Baseline, Day 113 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all enrolled participants who received treatment. |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Measure Participants | 29 |
Number [percentage of participants] |
93.1
321%
|
Title | Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113 |
---|---|
Description | 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. |
Time Frame | Baseline, Day 113 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all enrolled participants who received treatment. |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Measure Participants | 29 |
Number [percentage of participants] |
93.1
321%
|
Title | Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician |
---|---|
Description | 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. |
Time Frame | Baseline, Days 239 and 421 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all enrolled participants who received treatment. |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Measure Participants | 29 |
Day 239 |
100.0
344.8%
|
Day 421 |
96.6
333.1%
|
Title | Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient |
---|---|
Description | 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 |
Time Frame | Baseline, Days 239 and 421 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all enrolled participants who received treatment. |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Measure Participants | 29 |
Day 239 |
96.6
333.1%
|
Day 421 |
96.6
333.1%
|
Title | Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS) |
---|---|
Description | 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. |
Time Frame | Days 113, 239 and 421 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all enrolled participants who received treatment. |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Measure Participants | 29 |
Day 113 |
93.1
321%
|
Day 239 |
89.7
309.3%
|
Day 421 |
89.7
309.3%
|
Title | Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS) |
---|---|
Description | 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. |
Time Frame | Days 113, 239 and 421 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all enrolled participants who received treatment. |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Measure Participants | 29 |
Day 113 |
82.8
285.5%
|
Day 239 |
82.8
285.5%
|
Day 421 |
79.3
273.4%
|
Title | Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others |
---|---|
Description | |
Time Frame | Days 113, 239 and 421 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all enrolled participants who received treatment. |
Arm/Group Title | JUVÉDERM VOLUMA® |
---|---|
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. |
Measure Participants | 29 |
Day 113 |
89.7
309.3%
|
Day 239 |
89.7
309.3%
|
Day 421 |
86.2
297.2%
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | JUVÉDERM VOLUMA® | |
Arm/Group Description | Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection. | |
All Cause Mortality |
||
JUVÉDERM VOLUMA® | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
JUVÉDERM VOLUMA® | ||
Affected / at Risk (%) | # Events | |
Total | 0/29 (0%) | |
Other (Not Including Serious) Adverse Events |
||
JUVÉDERM VOLUMA® | ||
Affected / at Risk (%) | # Events | |
Total | 29/29 (100%) | |
General disorders | ||
Injection site swelling | 28/29 (96.6%) | |
Injection site erythema | 20/29 (69%) | |
Injection site bruising | 16/29 (55.2%) | |
Injection site pain | 11/29 (37.9%) | |
Injection site discomfort | 8/29 (27.6%) | |
Injection site hypoaesthesia | 2/29 (6.9%) | |
Injection site reaction | 2/29 (6.9%) | |
Infections and infestations | ||
Nasopharyngitis | 3/29 (10.3%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Therapeutic Area Head, |
---|---|
Organization | Allergan, Inc |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- VOLXC-AP-ND-001