Nasolabial Fold
Conditions
Keywords
Hyaluronic Acid, Nasolabial Fold, Lidocaine
Brief summary
The purpose of this study is to evaluate the pain and safety associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.
Interventions
DEVICERestylane Lidocaine
Intradermal injection
DEVICERestylane
Intradermal injection
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Men or women aged 18 years or older of Chinese origin * Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study * Intent to undergo correction of both nasolabial folds(NLF) with a wrinkle severity in Wrinkle Severity Rating Scale(WSRS) of either 3 on both sides or 4 on both sides
Exclusion criteria
* Previous use of any permanent (non-biodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat below the level of the lower orbital rim * Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment * Previous tissue revitalisation treatment with laser or light, mesotherapy radiofrequency, chemical peeling or dermabrasion in the midface within 6 months before treatment * Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated * Other condition preventing the subject from entering the study in the Investigator's opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS) | Up to 60 minutes after Injection on Day of Treatment | Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) 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 participant's VAS mark is measured with a standard ruler. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | 15, 30, 45, and 60 minutes after injection | Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at 15, 30, 45 and 60 minutes after injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled no pain at the left end and the worst pain you can imagine at the rig |
Countries
China
Participant flow
Pre-assignment details
Total 70 subjects enrolled and each subject has 2 NLFs, in total 70 NLFs were injected with Rstylane, opposite 70 NLFs was Restylane Lido.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: Intradermal injection | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 68 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized Han Chinese | 70 Participants |
| Region of Enrollment China | 70 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 8 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS)
Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) 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 participant's VAS mark is measured with a standard ruler.
Time frame: Up to 60 minutes after Injection on Day of Treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants | Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS) | 77.1 percentage of subjects |
Secondary
Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at 15, 30, 45 and 60 minutes after injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled no pain at the left end and the worst pain you can imagine at the rig
Time frame: 15, 30, 45, and 60 minutes after injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants | Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 15 minutes | 55.7 percentage of subjects |
| All Study Participants | Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 30 minutes | 48.6 percentage of subjects |
| All Study Participants | Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 45 minutes | 35.7 percentage of subjects |
| All Study Participants | Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 60 minutes | 31.4 percentage of subjects |