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

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.

Conditions
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Lip Enhancement

Intervention / Treatment
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* Device: hyaluronic acid gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juvéderm® Ultra Lip Injectable Gel<br> | Device: hyaluronic acid gel<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 3 months | 
| 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. | 1-12 months | 
| Adverse Events |  | 12 months |