An interventional study of YVOIRE Y-Solution 360 and Juvéderm VOLBELLA in Lip Augmentation, sponsored by LG Chem. Terminated at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by LG Chem · Not applicable, Interventional, and Treatment
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area
LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hyaluronic acid dermal filler
Device: YVOIRE Y-Solution 360
Hyaluronic acid dermal filler
Device: Juvéderm VOLBELLA
Hyaluronic acid dermal filler
Hyaluronic acid dermal filler
Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the mean change from baseline to 12 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). LFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Pronounced), and 4 (Very Pronounced).
Time frame: 12 weeks from baseline
Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Lip Fullness Rating Scale (LFRS) from baseline to 12 weeks will be calculated.
Time frame: 12 weeks from baseline
Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS).
Time frame: 2, 4, 12, 24 weeks from baseline
Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the responder rate (defined as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS).
Time frame: 2, 4, 12, 24 weeks from baseline
Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS).
Time frame: 2, 4, 12, 24 weeks from baseline
Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the responder rate (as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS).
Time frame: 2, 4, 12, 24 weeks from baseline
Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.
To measure the satisfaction of YVOIRE Y-Solution 360 the GAIS evaluation will be performed by subject and investigator. GAIS Grade are -2 (Much Worse), -1 (Worse), 0 (No change), 1 (Improved), and 2 (Much improved).
Time frame: 2, 4, 12, 24 weeks from baseline
Plan to share: No
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This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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LG Chem