Chin Augmentation
Conditions
Keywords
lower face, Mid face
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.
Interventions
DEVICERestylane Shaype
Injection
DEVICERestylane Defyne
Injection
DEVICERestylane Lyft lidocaine
Injection
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 | At week 8 |
Secondary
| Measure | Time frame |
|---|---|
| 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 Rated Improved or Much Improved or Very Much Improved as Assessed by Investigator Using the GAIS at Week 4 | At week 4 |
| 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 in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8 | At week 8 |
Countries
Canada
Outcome results
None listed