Nasolabial Fold
Conditions
Brief summary
The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale
Interventions
Intradermal injection
DEVICERestylane Perlane
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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent to participate in the study. * Men or women aged 20 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 grade 3 on both NLFs or grade 4 on both NLFs.
Exclusion criteria
* Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant 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 revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, 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 Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | At the time of injection | Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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 Perlane Side - Restylane Perlane 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 Perlane-Lido compared to Perlane 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 right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Perlane Lidocaine and Restylane Perlane Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1
Restylane Perlane Lidocaine: Intradermal injection
Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1
Restylane Perlane: Intradermal injection | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Restylane Perlane Lidocaine and Restylane Perlane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants |
| Age, Continuous | 50.2 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Han Chinese | 70 Participants |
| Region of Enrollment Taiwan | 70 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 7 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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: At the time of injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Perlane Lidocaine and Restylane Perlane | Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | 87.1 percentage of subjects |
Secondary
Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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 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: 15, 30, 45, and 60 minutes after injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Perlane Lidocaine and Restylane Perlane | Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 15 minutes | 64.3 percentage of subjects |
| Restylane Perlane Lidocaine and Restylane Perlane | Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 30 minutes | 42.9 percentage of subjects |
| Restylane Perlane Lidocaine and Restylane Perlane | Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 45 minutes | 31.4 percentage of subjects |
| Restylane Perlane Lidocaine and Restylane Perlane | Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | after 60 minutes | 24.3 percentage of subjects |