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Not yet recruiting NCT07566286

Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region

No phase Interventional Chin Augmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Restylane Lyft with Lidocaine.
Who it may be relevant to
Registry conditions: Chin Augmentation. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multicenter Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile

Overview

The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.

Interventions

  • Device Restylane Lyft with Lidocaine
    Sterile gel of hyaluronic acid.

Primary outcome measures

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment [Time frame: From Month 12 up to 3 months after optional retreatment (i.e. Month 15)]

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 or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
  • Known/previous allergy or hypersensitivity to 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 subnasale.
  • Any previous aesthetic procedures or implants.
  • Presence of any disease or lesions near or on the area to be treated.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Galderma Investigational Site # 8680 — Westport
  • Galderma Investigational Site # 8774 — Boynton Beach
  • Galderma Investigational Site # 7030 — Coral Gables
  • Galderma Investigational Site # 8682 — Coral Gables
  • Galderma Investigational Site # 7042 — Atlanta
  • Galderma Investigational Site # 7043 — Bethesda
  • Galderma Investigational Site # 7118 — Nashville
  • Galderma Investigational Site # 8662 — Spring

Identifiers

NCT: NCT07566286 · 05DF2506

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗