The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
62
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
Unnamed facility
Belfast, United Kingdom
Unnamed facility
Cheadle, United Kingdom
Unnamed facility
Halesowen, United Kingdom
Unnamed facility
Sutton Coldfield, United Kingdom
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
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
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
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
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
Adverse Events
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Time frame: 12 months