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
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
1 other identifier
interventional
45
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2024
CompletedFirst Submitted
Initial submission to the registry
May 20, 2024
CompletedFirst Posted
Study publicly available on registry
May 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2024
CompletedJanuary 31, 2025
May 1, 2024
2 months
May 20, 2024
January 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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 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 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
Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8
At week 8
- +1 more secondary outcomes
Study Arms (3)
Restylane Shaype
EXPERIMENTALParticipants will receive Restylane Shaype in the chin area only.
Restylane Shaype with Restylane Defyne
OTHERParticipants 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
OTHERParticipants 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.
Interventions
Injection
Injection
Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (3)
Galderma Investigational Site # 8754
Vancouver, British Columbia, V6H 4E1, Canada
Galderma Investigational Site 8379
Burlington, Ontario, L7N3N2, Canada
Galderma Investigational Site 8690
Westmount, Quebec, H3Z 1C3, Canada
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 20, 2024
First Posted
May 24, 2024
Study Start
May 13, 2024
Primary Completion
July 25, 2024
Study Completion
September 24, 2024
Last Updated
January 31, 2025
Record last verified: 2024-05