NCT03967444

Brief Summary

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 1, 2021

Completed
Last Updated

August 26, 2022

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

May 27, 2019

Results QC Date

October 8, 2020

Last Update Submit

August 24, 2022

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (1)

  • Assess Treatment With Restylane Kysse Using GAIS

    The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.

    8 weeks after last treatment

Study Arms (2)

Restylane Kysse

OTHER

Hyaluronic acid

Device: Hyaluronic acid

Restylane Kysse with other HA

OTHER

Hyaluronic acid

Device: Hyaluronic acid

Interventions

Hyaluronic acidDEVICE

Injectable gel for lip augmentation

Also known as: Restylane Kysse
Restylane Kysse

Eligibility Criteria

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

You may qualify if:

  • Signed and dated informed consent to participate in the study
  • Adult women and men who intend to undergo lip augmentation

You may not qualify if:

  • Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
  • Subjects with a previous implant other than HA in or near the intended treatment site
  • Participation in any other clinical study within three (3) months before treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Galderma Study Site

Montreal, Canada

Location

Galderma Study Site

Toronto, Canada

Location

Results Point of Contact

Title
Director of Clinical Operations
Organization
Galderma Research & Development, Aesthetics
aestheticclinicaltrials@galderma.com
817-961-5655

Study Officials

  • Study Director

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 30, 2019

Study Start

May 29, 2019

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

August 26, 2022

Results First Posted

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)