Trial Outcomes & Findings for Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand (NCT NCT06372782)
NCT ID: NCT06372782
Last Updated: 2025-10-10
Results Overview
The VAS is a subjective scale to measure pain intensity. Total range is 0-100, 0 represents no pain and 100 represents the worst pain you can imagine, meaning a lower value is considered a better outcome in terms of a less painful treatment. The subject shall be instructed to put a vertical mark, approximating the pain experienced after the procedure, on a 100 mm horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the subject's VAS mark shall be measured with a standard ruler. Each hand will be evaluated independently.
COMPLETED
NA
90 participants
End of Injection (T0)
2025-10-10
Participant Flow
Total 90 participants were enrolled in this study, each participant received Restylane Skinbooster vital lidocaine treatment on one hand, and Restylane Vital on his/her other hand.
Unit of analysis: Hands
Participant milestones
| Measure |
All Study Participants
Each subject received treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned.
|
|---|---|
|
Overall Study
STARTED
|
90 180
|
|
Overall Study
Restylane Skinboosters Vital Lidocaine-treated Hand
|
90 90
|
|
Overall Study
Restylane Vital-treated Hand
|
90 90
|
|
Overall Study
COMPLETED
|
90 180
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand
Baseline characteristics by cohort
| Measure |
Restylane Skinboosters Vital Lidocaine and Restylane Vital
n=90 Participants
Subjects' hands treated by Restylane Skinboosters Vital Lidocaine and Restylane Vital
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
40.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese Origin
|
90 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of Injection (T0)The VAS is a subjective scale to measure pain intensity. Total range is 0-100, 0 represents no pain and 100 represents the worst pain you can imagine, meaning a lower value is considered a better outcome in terms of a less painful treatment. The subject shall be instructed to put a vertical mark, approximating the pain experienced after the procedure, on a 100 mm horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the subject's VAS mark shall be measured with a standard ruler. Each hand will be evaluated independently.
Outcome measures
| Measure |
Restylane Skinboosters Vital Lidocaine
n=90 Participants
Subject's one hand treated by Restylane Skinboosters Vital Lidocaine
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand.
|
Restylane Vital
n=90 Participants
Subject's one hand treated by Restylane Vital.
Each subject will receive treatment on Day 1 with Restylane Vital Lidocaine in another hand.
|
|---|---|---|
|
The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0).
|
32.5 score on a scale
Standard Deviation 19.41
|
46.9 score on a scale
Standard Deviation 23.43
|
Adverse Events
Restylane Skinboosters Vital Lidocaine and Restylane Vital
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restylane Skinboosters Vital Lidocaine and Restylane Vital
n=90 participants at risk
Subjects' hands treated by Restylane Skinboosters Vital Lidocaine and Restylane Vital
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned.
|
|---|---|
|
Eye disorders
Conjunctival deposit
|
1.1%
1/90 • Number of events 1 • Through study completion, up to 1 month.
|
|
General disorders
Asthenia
|
1.1%
1/90 • Number of events 2 • Through study completion, up to 1 month.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/90 • Number of events 1 • Through study completion, up to 1 month.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.1%
1/90 • Number of events 1 • Through study completion, up to 1 month.
|
|
Nervous system disorders
Migraine
|
1.1%
1/90 • Number of events 1 • Through study completion, up to 1 month.
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/90 • Number of events 1 • Through study completion, up to 1 month.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place