Study to Evaluate Satisfaction After Treatment With Kysse

August 24, 2022 updated by: Galderma R&D

Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montréal, Canada
        • Galderma Study Site
      • Toronto, Canada
        • Galderma Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Restylane Kysse
Hyaluronic acid
Device: Hyaluronic acid
Injectable gel for lip augmentation
Other Names:
  • Restylane Kysse
Device: Hyaluronic acid
Injectable gel. Lip Augmentation and other wrinkles/folds
Other Names:
  • Restylane Kysse with other Restylane products
OTHER: Restylane Kysse with other HA
Hyaluronic acid
Device: Hyaluronic acid
Injectable gel for lip augmentation
Other Names:
  • Restylane Kysse
Device: Hyaluronic acid
Injectable gel. Lip Augmentation and other wrinkles/folds
Other Names:
  • Restylane Kysse with other Restylane products

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Treatment With Restylane Kysse Using GAIS
Time Frame: 8 weeks after last treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2019

Primary Completion (ACTUAL)

September 18, 2019

Study Completion (ACTUAL)

September 18, 2019

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (ACTUAL)

May 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05DF1807

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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