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

NCT ID: NCT02216851

Last Updated: 2022-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Nasal Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Restylane Perlane

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

Group Type EXPERIMENTAL

Restylane Perlane

Intervention Type DEVICE

Intradermal injection

No-treatment control

No-treatment control group do not receive any treatment during the main study period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Restylane Perlane

Intradermal injection

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Q-Med AB

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Beijing, , China

Site Status

Guangzhou, , China

Site Status

Countries

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China

Other Identifiers

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43CH1310

Identifier Type: -

Identifier Source: org_study_id

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