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

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Galderma

Status

Completed

Conditions

Volume Deficit in the Hand

Treatments

Device: Restylane Lyft with Lidocaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02650921
43USH1501

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

92 participants in 2 patient groups

Restylane Lyft with Lidocaine
Experimental group
Treatment:
Device: Restylane Lyft with Lidocaine
No Intervention
No Intervention group

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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