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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Volume Deficit in the Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Restylane Lyft with Lidocaine

Group Type EXPERIMENTAL

Restylane Lyft with Lidocaine

Intervention Type DEVICE

An injectable gel of Hyaluronic Acid and Lidocaine

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Restylane Lyft with Lidocaine

An injectable gel of Hyaluronic Acid and Lidocaine

Intervention Type DEVICE

Eligibility Criteria

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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 .

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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes