Nasal Augmentation
Conditions
Keywords
hyaluronic acid, no-treatment control, enhancement
Brief summary
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group
Interventions
DEVICERestylane Perlane
Intradermal injection
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chinese origin * Subject with desire to shape the nasal dorsum and/or nasal root * Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane
Exclusion criteria
* Subjects with previous nasal surgery, including grafts or implants to the nose area * Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome * Subjects with a history of chronic sinusitis or rhinitis * Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control | 6 months | The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Perlane Single injection of Restylane Perlane in nasal dorsum and/or nasal root
Restylane Perlane: Intradermal injection | 98 |
| No-treatment Control No-treatment control group do not receive any treatment during the main study period | 33 |
| Total | 131 |
Baseline characteristics
| Characteristic | Restylane Perlane | No-treatment Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants | 33 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 33 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 94 Participants | 33 Participants | 127 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 33 |
| other Total, other adverse events | 0 / 98 | 0 / 33 |
| serious Total, serious adverse events | 4 / 98 | 1 / 33 |
Outcome results
Primary
Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restylane Perlane | Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control | 0.82 mL | Standard Error 0.03 |
| No-treatment Control | Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control | 0.11 mL | Standard Error 0.03 |