NCT02650921

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 13, 2018

Completed
Last Updated

August 26, 2022

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

December 21, 2015

Results QC Date

October 3, 2018

Last Update Submit

August 24, 2022

Conditions

Volume Deficit in the Hand

Outcome Measures

Primary Outcomes (1)

  • Responder Rate Using Validated Hand Grading Scale

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

    12 Weeks

Secondary Outcomes (28)

  • Responder Rate Using Validated Hand Grading Scale

    16 weeks

  • Responder Rate Using Validated Hand Grading Scale

    20 weeks

  • Responder Rate Using Validated Hand Grading Scale

    24 weeks

  • Improvement in Hand as Evaluated by IPR

    12 weeks

  • Improvement in Hand as Evaluated by IPR

    16 weeks

  • +23 more secondary outcomes

Study Arms (2)

Restylane Lyft with Lidocaine

EXPERIMENTAL
Device: Restylane Lyft with Lidocaine

No Intervention

NO INTERVENTION

Interventions

Restylane Lyft with LidocaineDEVICE

An injectable gel of Hyaluronic Acid and Lidocaine

Restylane Lyft with Lidocaine

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Vista, California, United States

Location

Unknown Facility

Boulder, Colorado, United States

Location

Unknown Facility

Englewood, Colorado, United States

Location

Unknown Facility

Boca Raton, Florida, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Mount Kisco, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Related Publications (1)

  • 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.

    PMID: 31568288DERIVED

Results Point of Contact

Title
Assoc Director of Clinical Operations
Organization
Galderma Research & Development, LLC
courtney.maguire@galderma.com
817-961-5000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2015

First Posted

January 8, 2016

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

August 26, 2022

Results First Posted

December 13, 2018

Record last verified: 2018-11

Locations

US(7)