Nasolabial Folds in Chinese Population
Conditions
Keywords
hyaluronic acid, comparative study, NLF
Brief summary
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.
Interventions
DEVICERestylane Perlane
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
* Chinese origin * Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side. * Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period. * Singed Informed Consent
Exclusion criteria
* Subjects with traumatic scars or ongoing active skin disease in the area to be treated * Permanent inplant or filler, including fat injection placed in the area to be treated * Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion * Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months | 6 months | The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Perlane in One NLF and Restylane in the Other NLF Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design).
Restylane Perlane: Intradermal injection, Restylane: Intradermal injection | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Restylane Perlane in One NLF and Restylane in the Other NLF |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants |
| Race/Ethnicity, Customized Ethnicity Han Chinese | 97 Participants |
| Race/Ethnicity, Customized Ethnicity Other (Manchu, Tujia, Hui) | 3 Participants |
| Region of Enrollment China | 100 Participants |
| Sex: Female, Male Sex Female | 98 Participants |
| Sex: Female, Male Sex Male | 2 Participants |
| WSRS score of either 3 on both sides or 4 on both sides as assessed by an Independent Evaluator | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 16 / 100 |
| serious Total, serious adverse events | 2 / 100 |
Outcome results
Primary
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).
Time frame: 6 months
Population: Split-face design; 100 participants received treatment with Restylane Perlane in one NLF and treatment with Restylane in the other NLF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restylane Perlane NLFs | Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months | -0.03 units on a scale | Standard Deviation 0.03 |
| Restylane NLFs | Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months | 0.03 units on a scale | Standard Deviation 0.03 |