Trial Outcomes & Findings for JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose (NCT NCT01846039)

NCT ID: NCT01846039

Last Updated: 2019-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Baseline, Day 113

Results posted on

2019-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	JUVÉDERM VOLUMA® Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Overall Study STARTED	29
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	JUVÉDERM VOLUMA® Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Overall Study Protocol Violation	1
Overall Study Subject Withdrew Consent	1

Baseline Characteristics

JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Age, Continuous	40.2 years STANDARD_DEVIATION 11.78 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 113

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

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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
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	93.1 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Day 113

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

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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113	93.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 239 and 421

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

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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician Day 239	100.0 percentage of participants
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician Day 421	96.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 239 and 421

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

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

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient Day 239	96.6 percentage of participants
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient Day 421	96.6 percentage of participants

SECONDARY outcome

Timeframe: Days 113, 239 and 421

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

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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS) Day 113	93.1 percentage of participants
Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS) Day 239	89.7 percentage of participants
Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS) Day 421	89.7 percentage of participants

SECONDARY outcome

Timeframe: Days 113, 239 and 421

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

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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS) Day 113	82.8 percentage of participants
Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS) Day 239	82.8 percentage of participants
Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS) Day 421	79.3 percentage of participants

SECONDARY outcome

Timeframe: Days 113, 239 and 421

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

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® n=29 Participants Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others Day 113	89.7 percentage of participants
Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others Day 239	89.7 percentage of participants
Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others Day 421	86.2 percentage of participants

Adverse Events

JUVÉDERM VOLUMA®

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	JUVÉDERM VOLUMA® n=29 participants at risk Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
General disorders Injection site swelling	96.6% 28/29
General disorders Injection site erythema	69.0% 20/29
General disorders Injection site bruising	55.2% 16/29
General disorders Injection site pain	37.9% 11/29
General disorders Injection site discomfort	27.6% 8/29
General disorders Injection site hypoaesthesia	6.9% 2/29
General disorders Injection site reaction	6.9% 2/29
Infections and infestations Nasopharyngitis	10.3% 3/29

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER