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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02650921

Enrollment

Registered

2016-01-08

Start date

2015-12-31

Completion date

2016-12-31

Last updated

2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volume Deficit in the Hand

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.

Interventions

DEVICERestylane Lyft with Lidocaine

An injectable gel of Hyaluronic Acid and Lidocaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Responder Rate Using Validated Hand Grading Scale	12 Weeks	A responder is defined as a hand with at least one improvement from baseline.

Secondary

Measure	Time frame	Description
Improvement in Hand as Evaluated by IPR	12 weeks	Independent Photographic Reviewer's assessment of improvement (Yes/No)
GAIS by Treating Investigator	12 weeks	Global Aesthetic Improvement Scale
Evaluate GAIS by Subjects	12 weeks	Global Aesthetic Improvement Scale
Evaluate GAIS by Subject	24 weeks	Global Aesthetic Improvement Scale
Question 1 From Subject Satisfaction Questionnaire	Week 12	Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand
Question 2 From Subject Satisfaction Questionnaire	Week 12	Question 2: My treated hand appears more attractive than my untreated hand
Question 3 From Subject Satisfaction Questionnaire	Week 12	Question 3: My treated hand looks more youthful than my untreated hand
Question 4 From Subject Satisfaction Questionnaire	Week 12	Question 4: My treated hand feels softer than my untreated hand
Responder Rate Using Validated Hand Grading Scale	16 weeks	A responder is defined as a hand with at least one point improvement from baseline
Question 6 From Subject Satisfaction Questionnaire	Week 12	Question 6: My treated hand looks less bony than my untreated hand
Question 7 From Subject Satisfaction Questionnaire	Week 12	Question 7: The veins on my treated hand are less apparent compared to my untreated hand
Question 8 From Subject Satisfaction Questionnaire	Week 12	Question 8: My treated hand appears at least 5 years younger than my untreated hand
Question 9 From Subject Satisfaction Questionnaire	Week 12	Question 9: My treated hand appears at least 10 years younger than my untreated hand
Question 10 From Subject Satisfaction Questionnaire	Week 12	Question 10: The skin on my treated hand appears hydrated
Question 11 From Subject Satisfaction Questionnaire	Week 12	Question 11: The treatment result looks natural
Question 12 From Subject Satisfaction Questionnaire	Week 12	Question 12: I would recommend this treatment to a friend
Question 13 From Subject Satisfaction Questionnaire	Week 12	Question 13: I would have another treatment to maintain these results
Question 5 From Subject Satisfaction Questionnaire	Week 12	Question 5: The skin on my treated hand appears tighter than on my untreated hand

Countries

United States

Participant flow

Participants by arm

Arm	Count
Restylane Lyft With Lidocaine Restylane Lyft with Lidocaine: An injectable gel of Hyaluronic Acid and Lidocaine; Subjects were randomized to receive Restylane Lyft with Lidocaine in either the right or left hand.	85
Total	85

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Due to Medical Condition	1
Overall Study	Lost to Follow-up	2
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Restylane Lyft With Lidocaine
Age, Continuous	55.7 years STANDARD_DEVIATION 9.13
Fitzpatrick Skin Type FST I (Always burns, never tans)	4 Participants
Fitzpatrick Skin Type FST III (Sometimes mild burns, gradually tans)	39 Participants
Fitzpatrick Skin Type FST II (Usually burns, tans with difficulty)	21 Participants
Fitzpatrick Skin Type FST IV (Rarely burns, tans with ease)	12 Participants
Fitzpatrick Skin Type FST VI (Never burns, tans very easily)	2 Participants
Fitzpatrick Skin Type FST V (Very rarely burns, tans with ease)	7 Participants
Hand Grading Scale - Fellow Hand 0 (No loss of fatty tissue)	0 Participants
Hand Grading Scale - Fellow Hand 1 (Mild loss of fatty tissue)	0 Participants
Hand Grading Scale - Fellow Hand 2 (Moderate loss of fatty tissue)	18 Participants
Hand Grading Scale - Fellow Hand 3 (Severe loss of fatty tissue)	39 Participants
Hand Grading Scale - Fellow Hand 4 (Very severe loss of fatty tissue)	28 Participants
Hand Grading Scale - Treated hand 0 (No loss of fatty tissue)	0 Participants
Hand Grading Scale - Treated hand 1 (Mild loss of fatty tissue)	0 Participants
Hand Grading Scale - Treated hand 2 (Moderate loss of fatty tissue)	27 Participants
Hand Grading Scale - Treated hand 3 (Severe loss of fatty tissue)	31 Participants
Hand Grading Scale - Treated hand 4 (Very severe loss of fatty tissue)	27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	5 Participants
Race (NIH/OMB) More than one race	5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	71 Participants
Sex: Female, Male Female	82 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 89
other Total, other adverse events	37 / 89
serious Total, serious adverse events	0 / 89

Outcome results

Primary

Responder Rate Using Validated Hand Grading Scale

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

Time frame: 12 Weeks

Population: ITT population

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Restylane Lyft With Lidocaine	Responder Rate Using Validated Hand Grading Scale	Responder	73 Participants
Restylane Lyft With Lidocaine	Responder Rate Using Validated Hand Grading Scale	Non-Responder	12 Participants
No Intervention	Responder Rate Using Validated Hand Grading Scale	Responder	18 Participants
No Intervention	Responder Rate Using Validated Hand Grading Scale	Non-Responder	67 Participants

p-value: <0.000195% CI: [53.3, 76.1]McNemar

Secondary