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OpenTrials
Completed

NCT Number: NCT02216851

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

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

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Key information

Conditions

Nasal Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane Perlane

Device

Intradermal injection

Primary outcomes

  1. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 15, 2014
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.