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

Not Applicable

Completed

• Conditions: Chin Augmentation
• Interventions: Device: Restylane Shaype; Device: Restylane Defyne; Device: Restylane Lyft lidocaine

• Registration Number: NCT06428214
• Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-13
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Primary Completion: 2024-07-25
• Study Completion: 2024-09-24
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine	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.
Restylane Shaype	Restylane Shaype	Participants will receive Restylane Shaype in the chin area only.
Restylane Shaype with Restylane Defyne	Restylane Shaype	Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin.
Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine	Restylane Shaype	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.
Restylane Shaype with Restylane Defyne	Restylane Defyne	Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin.
Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine	Restylane Defyne	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8	At week 8
Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8	At week 8
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
Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8	At week 8
Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8	At week 8

Trial Locations

Locations (3)

Galderma Investigational Site 8379; 🇨🇦 Burlington, Ontario, Canada

Galderma Investigational Site # 8754; 🇨🇦 Vancouver, British Columbia, Canada

Galderma Investigational Site 8690; 🇨🇦 Westmount, Quebec, Canada