To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.

A 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.

A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.

Study Overview

• Status: Terminated
• Conditions: Lip Augmentation
• Intervention / Treatment: Device: YVOIRE Y-Solution 360; Device: Juvéderm VOLBELLA

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Potsdam, Germany
    • Haut-und Lasercentrum Potsdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female 18 years or above age.
• 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
• Agree to use proper contraception as guided in the protocol.
• Signed for Informed Consent.

Exclusion Criteria:

• have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
• who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
• have undergone oral surgery within 6 weeks
• have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
• have undergone semi-permanent filler in lower face within 24 months
• have undergone temporary dermal filler treatment in the lower face within 12 months
• Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
• Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
• have used lip plumping products within 10 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YVOIRE Y-Solution 360; Hyaluronic acid dermal filler	Device: YVOIRE Y-Solution 360; Hyaluronic acid dermal filler
Active Comparator: Juvéderm VOLBELLA; Hyaluronic acid dermal filler	Device: Juvéderm VOLBELLA; Hyaluronic acid dermal filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	2, 4, 12, 24 weeks from baseline

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Tanja C. Fischer, Haut-und Lasercentrum Potsdam

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LG-HACL023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No