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OpenTrials
Completed

NCT Number: NCT02432742

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

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.

Completed

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Key information

Conditions

Nasolabial Folds in Chinese Population

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane Perlane

Device

Intradermal injection

Restylane

Device

Intradermal injection

Primary outcomes

  1. Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 4, 2015
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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