N/A
N=131
Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
Nasal Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT02216851 ↗Enrolled (actual)
131
Serious AEs
3.8%
Results posted
Sep 2021
Primary outcome: 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 — 0.82; 0.11 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Perlane (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0.82; 0.11 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02216851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.