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Clinical Trial Details — Status: Active, not recruiting

Administrative data

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

Study information

Verified date May 2024
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Restylane Lyft with Lidocaine
hyaluronic acid
Juvederm Voluma XC
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.
See also
  Status Clinical Trial Phase
Completed NCT03597256 - Restylane Defyne for Correction of Chin Retrusion N/A
Active, not recruiting NCT06336772 - Restylane Shaype Versus Juvederm Volux for Chin Augmentation N/A
Completed NCT04559984 - JUVÉDERM VOLUX® for Chin Retrusion in China Phase 3
Completed NCT02833077 - A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation N/A
Completed NCT04687046 - A Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults Using Real-World Evidence
Completed NCT02559908 - A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw N/A
Completed NCT03624816 - A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion N/A
Recruiting NCT05986630 - Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face N/A