Clinical trial NCT06428214: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Augmentation
Keywords: lower face
Mid face
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: At week 8
Secondary outcomes:
measure: Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4
timeFrame: At week 4
measure: 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
timeFrame: At weeks 4 and 8
measure: Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8
timeFrame: At week 8
measure: Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8
timeFrame: At week 8
measure: Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8
timeFrame: At week 8
measure: Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8
timeFrame: At week 8
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Galderma Investigational Site # 8754
state: British Columbia
city: Burlington
country: Canada
facility: Galderma Investigational Site 8379
state: Ontario
city: Westmount
country: Canada
facility: Galderma Investigational Site 8690
state: Quebec
Study officials:
References: