Nasolabial Folds
Conditions
Keywords
Correction of Nasolabial Folds
Brief summary
Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
Detailed description
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Interventions
DEVICERestylane and Restylane-L
This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.
Sponsors
Q-Med Scandinavia, Inc.
Medicis Global Service Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects seeking augmentation therapy for correction of bilateral NLFs * Same WSRS score at both NLFs (either both Moderate \[3\] or both Severe \[4\]) * Subjects willing to give written informed consent to participate in the study * Women of childbearing potential willing to use an acceptable form of birth control during the study period
Exclusion criteria
* Active or chronic skin disease, inflammation or related conditions, near or on the NLFs * Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry * Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry * Permanent implant placed in the NLF area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Difference in Pain as Measured by a Visual Analogue Scale | After Injection on Day of Treatment | No pain is noted at 0 mm and worst pain is noted at 100 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wrinkle Improvement at Day 14 | 14 days after treatment when compared to baseline | This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Restylane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age Continuous | 52.1 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 60 | 46 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Treatment Difference in Pain as Measured by a Visual Analogue Scale
No pain is noted at 0 mm and worst pain is noted at 100 mm.
Time frame: After Injection on Day of Treatment
Population: This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restylane | Treatment Difference in Pain as Measured by a Visual Analogue Scale | 44.9 Scores on a VAS Scale | Standard Deviation 31.5 |
| Restylane-L | Treatment Difference in Pain as Measured by a Visual Analogue Scale | 14.7 Scores on a VAS Scale | Standard Deviation 17.7 |
Secondary
Wrinkle Improvement at Day 14
This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.
Time frame: 14 days after treatment when compared to baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane | Wrinkle Improvement at Day 14 | 60 participants |
| Restylane-L | Wrinkle Improvement at Day 14 | 59 participants |