Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds

NCT ID: NCT02432742

Last Updated: 2022-08-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.

Detailed Description

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Conditions

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Nasolabial Folds in Chinese Population

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Restylane Perlane

Single injection and optional touch up injection with Restylane Perlane in NLF

Group Type EXPERIMENTAL

Restylane Perlane

Intervention Type DEVICE

Intradermal injection

Restylane

Single injection and optional touch up injection with Restylane in NLF

Group Type ACTIVE_COMPARATOR

Restylane

Intervention Type DEVICE

Intradermal injection

Interventions

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Restylane Perlane

Intradermal injection

Intervention Type DEVICE

Restylane

Intradermal injection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chinese origin
* Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side.
* Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
* Singed Informed Consent

Exclusion Criteria

* Subjects with traumatic scars or ongoing active skin disease in the area to be treated
* Permanent inplant or filler, including fat injection placed in the area to be treated
* Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion
* Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion
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

Wuhan, , China

Site Status

Zhejiang, , China

Site Status

Countries

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China

Other Identifiers

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43CH1408

Identifier Type: -

Identifier Source: org_study_id

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