N/A
N=92
Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
Volume Deficit in the Hand
Bottom Line
View on ClinicalTrials.gov: NCT02650921 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Responder Rate Using Validated Hand Grading Scale — 73; 18; 12; 67 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Lyft with Lidocaine (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jul 2016
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 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 Improvement in Hand as Evaluated by IPR |
71; 18; 12; 65 | — |
| SECONDARY Improvement in Hand as Evaluated by IPR |
71; 18; 12; 65 | — |
| SECONDARY Improvement in Hand as Evaluated by IPR |
71; 18; 12; 65 | — |
| SECONDARY GAIS by Treating Investigator |
24; 1; 45; 0; 10; 0 | — |
| SECONDARY GAIS by Treating Investigator |
24; 1; 45; 0; 10; 0 | — |
| SECONDARY GAIS by Treating Investigator |
24; 1; 45; 0; 10; 0 | — |
| 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 Subjects |
21; 0; 34; 1; 22; 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 | — |
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.
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.