NCT04299295

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

October 14, 2021

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

March 2, 2020

Last Update Submit

October 7, 2021

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.

    2, 4, 12, 24 weeks from baseline

  • Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.

    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.

    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.

    2, 4, 12, 24 weeks from baseline

  • Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.

    2, 4, 12, 24 weeks from baseline

Study Arms (2)

YVOIRE Y-Solution 360

EXPERIMENTAL

Hyaluronic acid dermal filler

Device: YVOIRE Y-Solution 360

Juvéderm VOLBELLA

ACTIVE COMPARATOR

Hyaluronic acid dermal filler

Device: Juvéderm VOLBELLA

Interventions

YVOIRE Y-Solution 360DEVICE

Hyaluronic acid dermal filler

YVOIRE Y-Solution 360
Juvéderm VOLBELLADEVICE

Hyaluronic acid dermal filler

Juvéderm VOLBELLA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 18 years or above age.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haut-und Lasercentrum Potsdam

Potsdam, Germany

Location

Study Officials

  • Tanja C. Fischer

    Haut-und Lasercentrum Potsdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 6, 2020

Study Start

June 5, 2020

Primary Completion

December 7, 2020

Study Completion

March 1, 2021

Last Updated

October 14, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)