The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation
All subjects were randomized to either the treatment group, Juvederm(R) Ultra XC Injectable Gel, or to the control group (no treatment). At month 3, subjects in the control group crossed over to the treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
213
Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.
Unnamed facility
Nashville, Tennessee, United States
Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)
Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.
Time frame: Baseline, Month 3
Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale
Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).
Time frame: Baseline, Month 3
Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale
Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).
Time frame: Baseline, Month 3
Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness
Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'
Time frame: Baseline, Month 3
Duration Effect of Treatment on Lip Fullness
Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.
Time frame: Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.