JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01846039

Enrollment

Registered

2013-05-03

Start date

2013-04-01

Completion date

2014-08-05

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asian Nose Enhancement

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.

Interventions

DEVICECrosslinked hyaluronic acid gel

Up to 3 mL administered by intradermal injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 Who Would Recommend VOLUMA Treatment of the Nose to Others	Days 113, 239 and 421	—
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 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

Countries

Australia

Participant flow

Participants by arm

Arm	Count
JUVÉDERM VOLUMA® Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.	29
Total	29

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Protocol Violation	1
Overall Study	Subject Withdrew Consent	1

Baseline characteristics

Characteristic	JUVÉDERM VOLUMA®
Age, Continuous	40.2 years STANDARD_DEVIATION 11.78
Sex: Female, Male Female	26 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	29 / 29
serious Total, serious adverse events	0 / 29

Outcome results

Primary

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.

Time frame: Baseline, Day 113