Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile

Chin Retrusion Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05777759
• Other study ID #: 43USCH2208
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: July 2024
• Est. primary completion date: November 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chin Augmentation
• Chin Retrusion

Intervention

Device:
• New Dermal Filler
hyaluronic acid
• FDA appoved Dermal Filler
hyaluronic acid

Locations

Country	Name	City	State
Puerto Rico	Galderma Research Site	San Juan
United States	Galderma Research Site	Alpharetta	Georgia
United States	Galderma Research Site	Atlanta	Georgia
United States	Galderma Research Site	Aventura	Florida
United States	Galderma Research Site	Chestnut Hill	Massachusetts
United States	Galderma Research Site	Coral Gables	Florida
United States	Galderma Research Site	Los Angeles	California
United States	United States, California	Manhattan Beach	California
United States	Galderma Research Site	Nashville	Tennessee
United States	Galderma Research Site	Pflugerville	Texas
United States	Galderma Research Site	Rockville	Maryland
United States	Galderma Research Site	Westport	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Objective	Change from Baseline in the Blinded Evaluators' live assessment using the GCRS (Galderma Chin Retrusion Scale).	3 months after last treatment
Secondary	Secondary Effectiveness Objective	Responder rate based on the Blinded Evaluator's live assessment using the GCRS (Galderma Chin Retrusion Scale) at 6, 9, and 12 months after last treatment.	6, 9, and 12 months after last treatment.