Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
Not Applicable
Completed
- Conditions
- Nasal Augmentation
- Registration Number
- NCT02216851
- Lead Sponsor
- Galderma R&D
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method