Trial Outcomes & Findings for Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement (NCT NCT01176773)

Results Overview

The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

3 months

Results posted on

2014-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Juvéderm® Ultra Lip Injectable Gel
Overall Study STARTED	62
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Juvéderm® Ultra Lip Injectable Gel
Overall Study Screen Failure	2
Overall Study Withdrew consent	1

Baseline Characteristics

Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Juvéderm® Ultra Lip Injectable Gel n=60 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 12.14 • n=93 Participants
Sex: Female, Male Female	60 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United Kingdom	60 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Intent-to-treat

The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment

Outcome measures

Outcome measures
Measure	Juvéderm® Ultra Lip Injectable Gel n=59 Participants The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale	93.2 percentage of responders Interval 83.54 to 98.12

SECONDARY outcome

Timeframe: 12 months

Population: All subjects who were treated for perioral lines

Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.

Outcome measures

Outcome measures
Measure	Juvéderm® Ultra Lip Injectable Gel n=26 Participants The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale	1.5 units on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: 12 months

Population: All subjects who were treated in their oral commissures

Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.

Outcome measures

Outcome measures
Measure	Juvéderm® Ultra Lip Injectable Gel n=52 Participants The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale	1.6 units on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: 3 months

Population: All subjects with a Look and Feel assessment

The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result.

Outcome measures

Outcome measures
Measure	Juvéderm® Ultra Lip Injectable Gel n=60 Participants The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale Lips and Mouth Feel Soft	72.9 percentage of subjects
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale Lips Feel Natural	93.2 percentage of subjects
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale Lips Look Even	88.1 percentage of subjects
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale Lips Look Natural	89.8 percentage of subjects
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale Lips Feel Smooth	81.4 percentage of subjects

SECONDARY outcome

Timeframe: 1-12 months

Population: All subjects who provided a lip fullness goal achievement assessment

Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding "yes" as to whether their pre-established lip fullness treatment goal had been attained.

Outcome measures

Outcome measures
Measure	Juvéderm® Ultra Lip Injectable Gel n=60 Participants The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
Number of Subjects Who Attain Their Lip Treatment Goal Month 1 (n = 58)	98.3 percentage of subjects
Number of Subjects Who Attain Their Lip Treatment Goal Month 3 (n = 59)	98.3 percentage of subjects
Number of Subjects Who Attain Their Lip Treatment Goal Month 6 (n = 59)	86.4 percentage of subjects
Number of Subjects Who Attain Their Lip Treatment Goal Month 9 (n = 59)	86.4 percentage of subjects
Number of Subjects Who Attain Their Lip Treatment Goal Month 12 (n = 58)	56.9 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	Juvéderm® Ultra Lip Injectable Gel n=60 Participants The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
Adverse Events Bruising	51.7 percentage of subjects
Adverse Events Swelling	8.3 percentage of subjects
Adverse Events Lumps/bumps	8.3 percentage of subjects

Adverse Events

Juvéderm® Ultra Lip Injectable Gel

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Juvéderm® Ultra Lip Injectable Gel n=60 participants at risk
Nervous system disorders Nerve compression (unrelated to device)	1.7% 1/60 • Number of events 1

Other adverse events

Other adverse events
Measure	Juvéderm® Ultra Lip Injectable Gel n=60 participants at risk
General disorders Bruising	51.7% 31/60
General disorders Swelling	8.3% 5/60
General disorders Lumps/bumps	8.3% 5/60

Additional Information

Medical Monitor

Allergan Medical

Phone: (805) 961-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 120 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