N/A
Completed N=92
Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
Volume Deficit in the Hand
Source: ClinicalTrials.gov NCT02650921 ↗
Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Responder Rate Using Validated Hand Grading Scale — 73; 18; 12; 67 Participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate Using Validated Hand Grading Scale |
63; 25; 20; 58 | <0.0001 sig |
| SECONDARY Responder Rate Using Validated Hand Grading Scale |
63; 25; 20; 58 | <0.0001 sig |
| SECONDARY Improvement in Hand as Evaluated by IPR |
71; 18; 12; 65 | — |
| SECONDARY GAIS by Treating Investigator |
24; 1; 45; 0; 10; 0 | — |
| SECONDARY Evaluate GAIS by Subjects |
21; 0; 34; 1; 22; 0 | — |
| SECONDARY Evaluate GAIS by Subject |
21; 0; 26; 1; 30; 1 | — |
| SECONDARY Question 1 From Subject Satisfaction Questionnaire |
77; 7 | — |
| SECONDARY Question 2 From Subject Satisfaction Questionnaire |
74; 10 | — |
| SECONDARY Question 3 From Subject Satisfaction Questionnaire |
75; 9 | — |
| SECONDARY Question 4 From Subject Satisfaction Questionnaire |
44; 40 | — |
| SECONDARY Question 5 From Subject Satisfaction Questionnaire |
64; 20 | — |
| SECONDARY Question 6 From Subject Satisfaction Questionnaire |
78; 6 | — |
| SECONDARY Question 7 From Subject Satisfaction Questionnaire |
81; 3 | — |
| SECONDARY Question 8 From Subject Satisfaction Questionnaire |
59; 25 | — |
| SECONDARY Question 9 From Subject Satisfaction Questionnaire |
26; 58 | — |
| SECONDARY Question 10 From Subject Satisfaction Questionnaire |
57; 26 | — |
| SECONDARY Question 11 From Subject Satisfaction Questionnaire |
80; 4 | — |
| SECONDARY Question 12 From Subject Satisfaction Questionnaire |
71; 13 | — |
| SECONDARY Question 13 From Subject Satisfaction Questionnaire |
65; 19 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02650921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.