JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose | NCT01846039

NCT01846039

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
JUVÉDERM VOLUMA®	Experimental	Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.	Device: Crosslinked hyaluronic acid gel

Name	Type	Description	Arm Group Labels	Other Names
Crosslinked hyaluronic acid gel	Device	Up to 3 mL administered by intradermal injection	JUVÉDERM VOLUMA®

Outcomes Module

Primary Outcomes

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	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	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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Medical Director	Allergan	Study Director

PubMed Identifier	Type	Citation	Retractions
27301371	Background	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.

ID	Title	Description
FG000	JUVÉDERM VOLUMA®	Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.

Baseline Characteristics Module

ID	Title	Description
BG000	JUVÉDERM VOLUMA®	Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Intent-to-treat population included all enrolled participants who received treatment.

Posted

Number

percentage of participants

Baseline, Day 113

ID	Title	Description
OG000	JUVÉDERM VOLUMA®	Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	JUVÉDERM VOLUMA®	Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.

Facility	Status	City	State	ZIP	Country	Contacts
		Sydney	New South Wales		Australia