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

Galderma R&D92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Volume Deficit in the Hand

Interventions

Restylane Lyft with LidocaineDEVICE

An injectable gel of Hyaluronic Acid and Lidocaine

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Vista, California, United States

Unnamed facility

Boulder, Colorado, United States

Unnamed facility

Englewood, Colorado, United States

Unnamed facility

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

Responder Rate Using Validated Hand Grading Scale

A responder is defined as a hand with at least one improvement from baseline.

Time frame: 12 Weeks

Secondary Outcomes

Responder Rate Using Validated Hand Grading Scale

A responder is defined as a hand with at least one point improvement from baseline

Time frame: 16 weeks

Responder Rate Using Validated Hand Grading Scale

A responder is defined as a hand with at least one point improvement from baseline

Time frame: 20 weeks

Responder Rate Using Validated Hand Grading Scale

A responder is defined as a hand with at least one point improvement from baseline.

Time frame: 24 weeks

Improvement in Hand as Evaluated by IPR

Independent Photographic Reviewer's assessment of improvement (Yes/No)

Time frame: 12 weeks

Improvement in Hand as Evaluated by IPR

Independent Photographic Reviewer's assessment of improvement (Yes/No)

Time frame: 16 weeks

Improvement in Hand as Evaluated by IPR

Independent Photographic Reviewer's assessment of improvement (Yes/No)

Time frame: 20 weeks

Improvement in Hand as Evaluated by IPR

Independent Photographic Reviewer's assessment of improvement (Yes/No)

Data from ClinicalTrials.gov

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Unnamed facility

St Louis, Missouri, United States

Unnamed facility

Mount Kisco, New York, United States

Unnamed facility

New York, New York, United States

Time frame: 24 weeks

GAIS by Treating Investigator