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Completed

NCT Number: NCT02650921

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

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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Key information

Conditions

Volume Deficit in the Hand

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Restylane Lyft with Lidocaine

Device

An injectable gel of Hyaluronic Acid and Lidocaine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2016
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.