Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root

Not Applicable

Completed

• Conditions: Nasal Augmentation
• Interventions: Device: Restylane Perlane

• 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

Study Timeline

• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Results First Submitted: 2021-07-05
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-22
• Results First Posted: 2021-09-23
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

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

Arm && Interventions

Group	Intervention	Description
Restylane Perlane	Restylane Perlane	Single injection of Restylane Perlane in nasal dorsum and/or nasal root

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