Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement
|ClinicalTrials.gov Identifier: NCT01176773|
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : July 12, 2012
Last Update Posted : October 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lip Enhancement||Device: hyaluronic acid gel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||January 2012|
|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
- Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale [ Time Frame: 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
- Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176773
|Belfast, United Kingdom|
|Cheadle, United Kingdom|
|Halesowen, United Kingdom|
|Sutton Coldfield, United Kingdom|