Dorsal Hands
Conditions
Brief summary
The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.
Interventions
DEVICERestylane Vital
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent * Chinese origin * Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions
Exclusion criteria
* Any previous non-permanent implant/filler in the hands * Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline * Any previous hand surgery * Any fibrosis or scarring or deformities on the hands * Advanced photoaged/photodamaged skin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. | 12 weeks | Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Vital in Both Hands | 9 |
| Restylane Vital in Randomized Hand, no Treatment in the Other | 100 |
| Total | 109 |
Baseline characteristics
| Characteristic | Restylane Vital in Randomized Hand, no Treatment in the Other | Restylane Vital in Both Hands | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 0 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 9 Participants | 101 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.2 | 42.2 years STANDARD_DEVIATION 8.2 | 48 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment China | 100 participants | 9 participants | 109 participants |
| Sex: Female, Male Female | 96 Participants | 9 Participants | 105 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 9 | 12 / 100 | 3 / 100 |
| serious Total, serious adverse events | 0 / 9 | 2 / 100 | 2 / 100 |
Outcome results
Primary
The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.
Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.
Time frame: 12 weeks
Population: The 9 subjects treated with Restylane Vital in both hands not included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restylane Vital in Randomized Hand | The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. | 0.85 units on a scale | Standard Deviation 0.59 |
| No-treatment Control Hand | The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. | 2.17 units on a scale | Standard Deviation 0.49 |