Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

August 24, 2022 updated by: Galderma R&D
This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
        • United States, California
      • San Diego, California, United States
        • United States, California
    • Florida
      • Miami, Florida, United States
        • United States, Florida
    • Georgia
      • Roswell, Georgia, United States
        • United States, Georgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
  • Males or females, 22 years of age or older
  • Subjects seeking augmentation therapy for the lips.

Exclusion Criteria:

  • History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
  • History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents
  • Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Restylane Silk with Lidocaine
Device: Restylane Silk with Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43USC1505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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