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

Nasolabial Folds in Chinese Population Clinical Trial

Official title:

A Randomised, Multi-center, Evaluator-blinded Study in China to Evaluate the Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432742
• Other study ID #: 43CH1408
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2021
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds in Chinese Population

Intervention

Device:
• Restylane Perlane
Intradermal injection
• Restylane
Intradermal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 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).	6 months