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

Not Applicable

Completed

• Conditions: Nasolabial Folds in Chinese Population
• Interventions: Device: Restylane; Device: Restylane Perlane

• Registration Number: NCT02432742
• Lead Sponsor: Galderma R&D

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-28
• Study Start: 2015-05
• Study First Posted: 2015-05-04
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Results First Submitted: 2020-11-26
• Results First Submitted QC: 2020-11-26
• Results First Posted: 2020-12-23
• Status Verified: 2021-02
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane	Restylane	Single injection and optional touch up injection with Restylane in NLF
Restylane Perlane	Restylane Perlane	Single injection and optional touch up injection with Restylane Perlane in NLF

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months	6 months	The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).