Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand

August 24, 2022 updated by: Galderma R&D

A Randomized, Evaluator Blinded, Split-hand Study to Evaluate the Effectiveness and Safety of Restylane Lyft With Lidocaine Compared to no Treatment for Injection in the Dorsal Hand to Correct Volume Deficit

This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Vista, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Englewood, Colorado, United States
    • Florida
      • Boca Raton, Florida, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New York
      • Mount Kisco, New York, United States
      • New York, New York, United States

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images.
  • Males or females, 22 years of age or older
  • Willing and able to perform hand functionality tests .

Key Exclusion Criteria:

  • History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
  • History of allergy or hypersensitivity to lidocaine or other amide type anesthetics.
  • Previous hand surgery including sclerotherapy, or history of hand trauma.
  • Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No Intervention
Experimental: Restylane Lyft with Lidocaine
Device: Restylane Lyft with Lidocaine
An injectable gel of Hyaluronic Acid and Lidocaine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Responder Rate Using Validated Hand Grading Scale
Time Frame: 12 Weeks
A responder is defined as a hand with at least one improvement from baseline.
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Responder Rate Using Validated Hand Grading Scale
Time Frame: 16 weeks
A responder is defined as a hand with at least one point improvement from baseline
16 weeks
Responder Rate Using Validated Hand Grading Scale
Time Frame: 20 weeks
A responder is defined as a hand with at least one point improvement from baseline
20 weeks
Responder Rate Using Validated Hand Grading Scale
Time Frame: 24 weeks
A responder is defined as a hand with at least one point improvement from baseline.
24 weeks
Improvement in Hand as Evaluated by IPR
Time Frame: 12 weeks
Independent Photographic Reviewer's assessment of improvement (Yes/No)
12 weeks
Improvement in Hand as Evaluated by IPR
Time Frame: 16 weeks
Independent Photographic Reviewer's assessment of improvement (Yes/No)
16 weeks
Improvement in Hand as Evaluated by IPR
Time Frame: 20 weeks
Independent Photographic Reviewer's assessment of improvement (Yes/No)
20 weeks
Improvement in Hand as Evaluated by IPR
Time Frame: 24 weeks
Independent Photographic Reviewer's assessment of improvement (Yes/No)
24 weeks
GAIS by Treating Investigator
Time Frame: 12 weeks
Global Aesthetic Improvement Scale
12 weeks
GAIS by Treating Investigator
Time Frame: 16 weeks
Global Aesthetic Improvement Scale
16 weeks
GAIS by Treating Investigator
Time Frame: 20 weeks
Global Aesthetic Improvement Scale
20 weeks
GAIS by Treating Investigator
Time Frame: 24 weeks
Global Aesthetic Improvement Scale
24 weeks
Evaluate GAIS by Subjects
Time Frame: 12 weeks
Global Aesthetic Improvement Scale
12 weeks
Evaluate GAIS by Subjects
Time Frame: 16 weeks
Global Aesthetic Improvement Scale
16 weeks
Evaluate GAIS by Subjects
Time Frame: 20 weeks
Global Aesthetic Improvement Scale
20 weeks
Evaluate GAIS by Subject
Time Frame: 24 weeks
Global Aesthetic Improvement Scale
24 weeks
Question 1 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand
Week 12
Question 2 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 2: My treated hand appears more attractive than my untreated hand
Week 12
Question 3 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 3: My treated hand looks more youthful than my untreated hand
Week 12
Question 4 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 4: My treated hand feels softer than my untreated hand
Week 12
Question 5 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 5: The skin on my treated hand appears tighter than on my untreated hand
Week 12
Question 6 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 6: My treated hand looks less bony than my untreated hand
Week 12
Question 7 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 7: The veins on my treated hand are less apparent compared to my untreated hand
Week 12
Question 8 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 8: My treated hand appears at least 5 years younger than my untreated hand
Week 12
Question 9 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 9: My treated hand appears at least 10 years younger than my untreated hand
Week 12
Question 10 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 10: The skin on my treated hand appears hydrated
Week 12
Question 11 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 11: The treatment result looks natural
Week 12
Question 12 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 12: I would recommend this treatment to a friend
Week 12
Question 13 From Subject Satisfaction Questionnaire
Time Frame: Week 12
Question 13: I would have another treatment to maintain these results
Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 43USH1501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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