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OpenTrials
Completed

NCT Number: NCT05777759

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

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

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Key information

Conditions

Chin Augmentation Chin Retrusion

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Restylane Lyft with Lidocaine

Device

hyaluronic acid

Juvederm Voluma XC

Device

hyaluronic acid

Primary outcomes

  1. Change From Baseline in the Blinded Evaluators' Live Assessment Using the Galderma Chin Retrusion Scale (GCRS) at Month 3

    Time frame: Baseline (last non-missing observation prior to the first administration of study product) and Month 3

    GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Least squares (LS) mean, and 95 percent (%) confidence interval (CI) were obtained from a general linear mixed random intercept model with treatment group and baseline Galderma Chin Retrusion Scale score as fixed factors.

Secondary outcomes

  1. Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12

    Time frame: At Months 6, 9, and 12

    GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Responder rate was defined as percentage of participants with an improvement of at least one grade on the GCRS from baseline. 95% CI was calculated using Clopper-Pearson method.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 21, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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