Nasolabial Folds in Chinese Population
Conditions
Keywords
Hyaluronic acid, Comparative study, NLF
Brief summary
This is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.
Interventions
DEVICERestylane Defyne
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
1. Signed informed consent. 2. Men or women aged 18 years of age or older of Chinese origin. 3. 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. 4. Intent to undergo correction of both NLFs with a wrinkle severity in WSRS of either 3 on both sides or 4 on both sides, as assessed by the blinded evaluator.
Exclusion criteria
1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) Gel and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics. 2. Previous tissue revitalization treatment below the level of the lower orbital rim within 6 months before treatment. 3. Previous surgery or tattoo in the area to be treated. 4. Previous tissue augmentation therapy or contouring with any permanent (nonbiodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat or permanent implant below the level of the lower orbital rim. 5. Previous use of neurotoxins or 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. 6. Scars or deformities, active skin disease, inflammation or related conditions such as infection, perioral dermatitis, seborrheic dermatitis, eczema, rosacea, acne, psoriasis, and herpes zoster near or in the area to be treated. 7. Other condition preventing the subject from entering the study in the Investigator's opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS. | 6 month | The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone |
Countries
China
Participant flow
Pre-assignment details
Each subject have 2 NLFs, the right/left one. According to protocol that Each subject will be randomized to one of two treatment sequences; either Restylane Defyne in the right NLF followed by Restylane in the left NLF, or Restylane in the right NLF followed by Restylane Defyne in the left NLF. Arms/Groups are combined because right/left side is not statistical factors.
Participants by arm
| Arm | Count |
|---|---|
| Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF Restylane Defyne treated in the right NLF followed by Restylane in the left NLF | 88 |
| Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF Restylane treated in the right NLF followed by Restylane Defyne in the left NLF | 87 |
| Total | 175 |
Baseline characteristics
| Characteristic | Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF | Total | Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 174 Participants | 88 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 8.7 | NA years | 44 years STANDARD_DEVIATION 8.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 87 Participants | 175 Participants | 88 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 87 participants | 175 participants | 88 participants |
| Sex: Female, Male Female | 83 Participants | 166 Participants | 83 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 0 / 175 |
| other Total, other adverse events | 0 / 175 | 0 / 175 |
| serious Total, serious adverse events | 3 / 175 | 3 / 175 |
Outcome results
Primary
Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.
The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone
Time frame: 6 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF | Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS. | 72.9 percentage of subjects |
| Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF | Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS. | 72.8 percentage of subjects |