A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies (ARTIST)

January 29, 2025 updated by: Galderma R&D

A Post-market, Open-label, 3-Armed, Parallel Group, Multicenter Study to Evaluate Aesthetic Improvement and Safety of Restylane Shaype for Temporary Augmentation of the Chin Region Alone or in Combination With Restylane Defyne and Restylane Lyft Lidocaine Treatment in the Lower Face and Midface

The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 4E1
        • Galderma Investigational Site # 8754
    • Ontario
      • Burlington, Ontario, Canada, L7N3N2
        • Galderma Investigational Site 8379
    • Quebec
      • Westmount, Quebec, Canada, H3Z 1C3
        • Galderma Investigational Site 8690

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
  • Males or non-pregnant, non-breastfeeding females, over the age of 18.
  • Intent to receive treatment for temporary augmentation in the chin region.

Exclusion Criteria:

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
  • Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
  • Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
  • Any previous aesthetic procedures or implants.
  • Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
  • Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline.
  • Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restylane Shaype
Participants will receive Restylane Shaype in the chin area only.
Device: Restylane Shaype
Injection
Other: Restylane Shaype with Restylane Defyne
Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin.
Device: Restylane Shaype
Injection
Device: Restylane Defyne
Injection
Other: Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine
Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Participants in this group will be treated with Restylane Lyft lidocaine in the midface, nasolabial folds (NLF) and /or jawline.
Device: Restylane Shaype
Injection
Device: Restylane Defyne
Injection
Device: Restylane Lyft lidocaine
Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8
Time Frame: At week 8
At week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4
Time Frame: At week 4
At week 4
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8
Time Frame: At weeks 4 and 8
At weeks 4 and 8
Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8
Time Frame: At week 8
At week 8
Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8
Time Frame: At week 8
At week 8
Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8
Time Frame: At week 8
At week 8
Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8
Time Frame: At week 8
At week 8

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 13, 2024

Primary Completion (Actual)

July 25, 2024

Study Completion (Actual)

September 24, 2024

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05DF2307

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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