Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement
This study has been completed.
Information provided by (Responsible Party):
First received: March 23, 2010
Last updated: December 23, 2013
Last verified: December 2013
The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Resource links provided by NLM:
Further study details as provided by Allergan Medical:
Primary Outcome Measures:
- Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]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:
- Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: 1-12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Juvéderm® Ultra Lip Injectable Gel||
Device: hyaluronic 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
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