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

Not Applicable

Completed

Conditions: Lip Enhancement

Interventions: Device: hyaluronic acid gel

Registration Number: NCT01176773

Lead Sponsor: Allergan Medical

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Juvéderm® Ultra Lip Injectable Gel	hyaluronic acid gel	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
Adverse Events	12 months