Clinical trial NCT05777759: Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
Official title: A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Augmentation
Chin Retrusion
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2023-03-21
Enrollment: 174
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for augmentation of the chin region to improve the chin profile.


Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant, non-breastfeeding females, 22 years of age or older
* Intent to receive treatment for augmentation and correction of retrusion in the chin region.

Exclusion Criteria:

* Known/previous allergy of hypersensitivity to any injectable hyaluronic acid (HA) gel or gram-positive bacterial proteins.
* Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics.
* Previous or present multiple severe allergies or severe allergies, such as manifested by anaphylaxis or angioedema or family history of angioedema.
* Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the subnasale.
* Any previous aesthetic procedures or implants
* Presence of any disease or lesion near or on the area to be treated.

Primary outcomes:
measure: Primary Effectiveness Objective
timeFrame: 3 months after last treatment
Secondary outcomes:
measure: Secondary Effectiveness Objective
timeFrame: 6, 9, and 12 months after last treatment.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Galderma Research Site
state: California
city: Manhattan Beach
country: United States
facility: United States, California
state: California
city: Westport
country: United States
facility: Galderma Research Site
state: Connecticut
city: Aventura
country: United States
facility: Galderma Research Site
state: Florida
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: Alpharetta
country: United States
facility: Galderma Research Site
state: Georgia
city: Atlanta
country: United States
facility: Galderma Research Site
state: Georgia
city: Rockville
country: United States
facility: Galderma Research Site
state: Maryland
city: Chestnut Hill
country: United States
facility: Galderma Research Site
state: Massachusetts
city: Nashville
country: United States
facility: Galderma Research Site
state: Tennessee
city: Pflugerville
country: United States
facility: Galderma Research Site
state: Texas
city: San Juan
country: Puerto Rico
facility: Galderma Research Site
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: