Lip Enhancement
Conditions
Brief summary
The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
Interventions
DEVICEhyaluronic acid gel
Dosage per Investigator's discretion to obtain lip treatment goal; 1 touch-up treatment is allowed 14 days after initial treatment. Maximum total volume per subject is 2.0 mL
Sponsors
Allergan Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Desire enhancement of his/her vermilion borders and/or vermilion mucosa Cupid's bow, philtral columns, perioral lines, and oral commissures may also be treated * Have a baseline score of Minimal of Mild, as assessed by the Investigator according to the 4-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked) * Have established a realistic Lip Fullness treatment goal that Investigator agrees is achievable
Exclusion criteria
* Have undergone cosmetic facial, lip or perioral procedures \[e.g., face-lift or other surgeries which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\] anywhere in the face or neck, or BOTOX® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. Note: Prior treatment with Hyaluronic Acid fillers and/or collage is allowed, provided the treatment was administered not less than 6 months prior to study entry * Have ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study * Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to local anaesthesia agents, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study * Are pregnant, lactating, or planning to become pregnant at any time during the study * Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study * Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study * Have a history of or currently suffer from autoimmune disease * Have a history of treatment with interferon for chronic hepatitis C * Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDs (e.g. aspirin, ibuprofen) or other substances known to increase coagulation time (e.g. herbal supplements with garlic or Gingko Biloba) within 10 days of undergoing study device injection. Note: Study device injection may be delayed as necessary to accommodate this 10-day wash out period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale | 12 months | Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement. |
| Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale | 12 months | Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement. |
| Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale | 3 months | 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. |
| Number of Subjects Who Attain Their Lip Treatment Goal | 1-12 months | 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. |
| Adverse Events | 12 months | — |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Juvéderm® Ultra Lip Injectable Gel | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 2 |
| Overall Study | Withdrew consent | 1 |
Baseline characteristics
| Characteristic | Juvéderm® Ultra Lip Injectable Gel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age, Continuous | 50.2 years STANDARD_DEVIATION 12.14 |
| Region of Enrollment United Kingdom | 60 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 60 |
| serious Total, serious adverse events | 1 / 60 |
Outcome results
Primary
Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale
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
Time frame: 3 months
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale | 93.2 percentage of responders |
Secondary
Adverse Events
Time frame: 12 months
Population: Intent-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Adverse Events | Bruising | 51.7 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Adverse Events | Swelling | 8.3 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Adverse Events | Lumps/bumps | 8.3 percentage of subjects |
Secondary
Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale
Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.
Time frame: 12 months
Population: All subjects who were treated in their oral commissures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale | 1.6 units on a scale | Standard Deviation 0.85 |
Secondary
Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale
Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.
Time frame: 12 months
Population: All subjects who were treated for perioral lines
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale | 1.5 units on a scale | Standard Deviation 0.69 |
Secondary
Number of Subjects Who Attain Their Lip Treatment Goal
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.
Time frame: 1-12 months
Population: All subjects who provided a lip fullness goal achievement assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Number of Subjects Who Attain Their Lip Treatment Goal | Month 1 (n = 58) | 98.3 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Number of Subjects Who Attain Their Lip Treatment Goal | Month 3 (n = 59) | 98.3 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Number of Subjects Who Attain Their Lip Treatment Goal | Month 6 (n = 59) | 86.4 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Number of Subjects Who Attain Their Lip Treatment Goal | Month 9 (n = 59) | 86.4 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Number of Subjects Who Attain Their Lip Treatment Goal | Month 12 (n = 58) | 56.9 percentage of subjects |
Secondary
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale
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.
Time frame: 3 months
Population: All subjects with a Look and Feel assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale | Lips Look Even | 88.1 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | 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 |
| Juvéderm® Ultra Lip Injectable Gel | Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale | Lips Feel Smooth | 81.4 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale | Lips Feel Natural | 93.2 percentage of subjects |
| Juvéderm® Ultra Lip Injectable Gel | Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale | Lips Look Natural | 89.8 percentage of subjects |