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

August 24, 2022 updated by: Galderma R&D

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Guangzhou, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Restylane Perlane
Single injection of Restylane Perlane in nasal dorsum and/or nasal root
Device: Restylane Perlane
Intradermal injection
NO_INTERVENTION: No-treatment control
No-treatment control group do not receive any treatment during the main study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (ESTIMATE)

August 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 43CH1310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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