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

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ClinicalTrials.gov Identifier: NCT02650921
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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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.

Condition or disease Intervention/treatment Phase
Volume Deficit in the Hand Device: Restylane Lyft with Lidocaine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Restylane Lyft with Lidocaine Device: Restylane Lyft with Lidocaine
An injectable gel of Hyaluronic Acid and Lidocaine
No Intervention: No Intervention


Outcome Measures
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Primary Outcome Measures :
  1. Responder Rate Using Validated Hand Grading Scale [ Time Frame: 12 Weeks ]
    A responder is defined as a hand with at least one improvement from baseline.


Secondary Outcome Measures :
  1. Responder Rate Using Validated Hand Grading Scale [ Time Frame: 16 weeks ]
    A responder is defined as a hand with at least one point improvement from baseline

  2. Responder Rate Using Validated Hand Grading Scale [ Time Frame: 20 weeks ]
    A responder is defined as a hand with at least one point improvement from baseline

  3. Responder Rate Using Validated Hand Grading Scale [ Time Frame: 24 weeks ]
    A responder is defined as a hand with at least one point improvement from baseline.

  4. Improvement in Hand as Evaluated by IPR [ Time Frame: 12 weeks ]
    Independent Photographic Reviewer's assessment of improvement (Yes/No)

  5. Improvement in Hand as Evaluated by IPR [ Time Frame: 16 weeks ]
    Independent Photographic Reviewer's assessment of improvement (Yes/No)

  6. Improvement in Hand as Evaluated by IPR [ Time Frame: 20 weeks ]
    Independent Photographic Reviewer's assessment of improvement (Yes/No)

  7. Improvement in Hand as Evaluated by IPR [ Time Frame: 24 weeks ]
    Independent Photographic Reviewer's assessment of improvement (Yes/No)

  8. GAIS by Treating Investigator [ Time Frame: 12 weeks ]
    Global Aesthetic Improvement Scale

  9. GAIS by Treating Investigator [ Time Frame: 16 weeks ]
    Global Aesthetic Improvement Scale

  10. GAIS by Treating Investigator [ Time Frame: 20 weeks ]
    Global Aesthetic Improvement Scale

  11. GAIS by Treating Investigator [ Time Frame: 24 weeks ]
    Global Aesthetic Improvement Scale

  12. Evaluate GAIS by Subjects [ Time Frame: 12 weeks ]
    Global Aesthetic Improvement Scale

  13. Evaluate GAIS by Subjects [ Time Frame: 16 weeks ]
    Global Aesthetic Improvement Scale

  14. Evaluate GAIS by Subjects [ Time Frame: 20 weeks ]
    Global Aesthetic Improvement Scale

  15. Evaluate GAIS by Subject [ Time Frame: 24 weeks ]
    Global Aesthetic Improvement Scale

  16. Question 1 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand

  17. Question 2 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 2: My treated hand appears more attractive than my untreated hand

  18. Question 3 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 3: My treated hand looks more youthful than my untreated hand

  19. Question 4 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 4: My treated hand feels softer than my untreated hand

  20. Question 5 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 5: The skin on my treated hand appears tighter than on my untreated hand

  21. Question 6 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 6: My treated hand looks less bony than my untreated hand

  22. Question 7 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 7: The veins on my treated hand are less apparent compared to my untreated hand

  23. Question 8 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 8: My treated hand appears at least 5 years younger than my untreated hand

  24. Question 9 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 9: My treated hand appears at least 10 years younger than my untreated hand

  25. Question 10 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 10: The skin on my treated hand appears hydrated

  26. Question 11 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 11: The treatment result looks natural

  27. Question 12 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 12: I would recommend this treatment to a friend

  28. Question 13 From Subject Satisfaction Questionnaire [ Time Frame: Week 12 ]
    Question 13: I would have another treatment to maintain these results


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650921


Locations
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United States, California
Vista, California, United States
United States, Colorado
Boulder, Colorado, United States
Englewood, Colorado, United States
United States, Florida
Boca Raton, Florida, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New York
Mount Kisco, New York, United States
New York, New York, United States
Sponsors and Collaborators
Q-Med AB
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT02650921    
Other Study ID Numbers: 43USH1501
First Posted: January 8, 2016    Key Record Dates
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action