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

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: Completed
• Conditions: Volume Deficit in the Hand
• Intervention / Treatment: Device: Restylane Lyft with Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Responder Rate Using Validated Hand Grading Scale	A responder is defined as a hand with at least one improvement from baseline.	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Using Validated Hand Grading Scale	A responder is defined as a hand with at least one point improvement from baseline	16 weeks
Responder Rate Using Validated Hand Grading Scale	A responder is defined as a hand with at least one point improvement from baseline	20 weeks
Responder Rate Using Validated Hand Grading Scale	A responder is defined as a hand with at least one point improvement from baseline.	24 weeks
Improvement in Hand as Evaluated by IPR	Independent Photographic Reviewer's assessment of improvement (Yes/No)	12 weeks
Improvement in Hand as Evaluated by IPR	Independent Photographic Reviewer's assessment of improvement (Yes/No)	16 weeks
Improvement in Hand as Evaluated by IPR	Independent Photographic Reviewer's assessment of improvement (Yes/No)	20 weeks
Improvement in Hand as Evaluated by IPR	Independent Photographic Reviewer's assessment of improvement (Yes/No)	24 weeks
GAIS by Treating Investigator	Global Aesthetic Improvement Scale	12 weeks
GAIS by Treating Investigator	Global Aesthetic Improvement Scale	16 weeks
GAIS by Treating Investigator	Global Aesthetic Improvement Scale	20 weeks
GAIS by Treating Investigator	Global Aesthetic Improvement Scale	24 weeks
Evaluate GAIS by Subjects	Global Aesthetic Improvement Scale	12 weeks
Evaluate GAIS by Subjects	Global Aesthetic Improvement Scale	16 weeks
Evaluate GAIS by Subjects	Global Aesthetic Improvement Scale	20 weeks
Evaluate GAIS by Subject	Global Aesthetic Improvement Scale	24 weeks
Question 1 From Subject Satisfaction Questionnaire	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	Question 2: My treated hand appears more attractive than my untreated hand	Week 12
Question 3 From Subject Satisfaction Questionnaire	Question 3: My treated hand looks more youthful than my untreated hand	Week 12
Question 4 From Subject Satisfaction Questionnaire	Question 4: My treated hand feels softer than my untreated hand	Week 12
Question 5 From Subject Satisfaction Questionnaire	Question 5: The skin on my treated hand appears tighter than on my untreated hand	Week 12
Question 6 From Subject Satisfaction Questionnaire	Question 6: My treated hand looks less bony than my untreated hand	Week 12
Question 7 From Subject Satisfaction Questionnaire	Question 7: The veins on my treated hand are less apparent compared to my untreated hand	Week 12
Question 8 From Subject Satisfaction Questionnaire	Question 8: My treated hand appears at least 5 years younger than my untreated hand	Week 12
Question 9 From Subject Satisfaction Questionnaire	Question 9: My treated hand appears at least 10 years younger than my untreated hand	Week 12
Question 10 From Subject Satisfaction Questionnaire	Question 10: The skin on my treated hand appears hydrated	Week 12
Question 11 From Subject Satisfaction Questionnaire	Question 11: The treatment result looks natural	Week 12
Question 12 From Subject Satisfaction Questionnaire	Question 12: I would recommend this treatment to a friend	Week 12
Question 13 From Subject Satisfaction Questionnaire	Question 13: I would have another treatment to maintain these results	Week 12

Collaborators and Investigators

• Sponsor: Galderma R&D

Publications and helpful links

General Publications

• Moradi A, Allen S, Bank D, Marmur E, Fagien S, Glaser DA, Maguire C, Cohen JL. A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand. Plast Reconstr Surg. 2019 Oct;144(4):586e-596e. doi: 10.1097/PRS.0000000000006070.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 43USH1501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided