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OpenTrials
Completed

NCT Number: NCT03160716

Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.

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Key information

Conditions

Cheek Augmentation Midface Contour Deficiencies

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facial Plastic and Cosmetic Surgery, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Primary Inclusion Criteria:

  • Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
  • Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
  • Mild to Substantial Midface Volume Loss

Primary Exclusion Criteria:

  • Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
  • Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents
  • Undergone prior surgery to midface

Treatment and study plan

Restylane Lyft with Lidocaine

Device

a sterile gel of hyaluronic acid (HA)

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events [Safety]

    Time frame: 16 weeks

    To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.

Secondary outcomes

  1. Number of Participants With Aesthetic Improvement

    Time frame: 16 weeks

    To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as "Improved" or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).

  2. Number of Participants That Responded to Treatment

    Time frame: 16 weeks

    To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).

  3. Subject Satisfaction

    Time frame: 8 weeks

    To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multicenter, Open-Label, Prospective Study of Cannula Injection of Restylane Lyft With Lidocaine for Cheek Augmentation and the Correction of Age Related Midface Contour Deficiencies

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 19, 2017
Registry last updated
Aug 26, 2022

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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