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

Chin Augmentation Clinical Trial

— ARTIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428214
• Other study ID #: 05DF2307
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: September 10, 2024

Study information

• Verified date: May 2024
• Source: Galderma R&D
• Contact: Galderma Research & Development
• Phone: 1-866-735-4137
• Email: clinical.studies[@]galderma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chin Augmentation

Intervention

Device:
• Restylane Shaype
Injection
• Restylane Defyne
Injection
• Restylane Lyft lidocaine
Injection

Locations

Country	Name	City	State
Canada	Galderma Investigational Site 8379	Burlington	Ontario
Canada	Galderma Investigational Site # 8754	Vancouver	British Columbia
Canada	Galderma Investigational Site 8690	Westmount	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

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