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

Galderma

Status: Completed

Conditions: Nasolabial Folds in Chinese Population

Treatments: Device: Restylane; Device: Restylane Perlane

Study type: Interventional

Funder types: Industry

Identifiers

NCT02432742

43CH1408

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Restylane Perlane

Experimental group

Description:

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

Treatment:

Device: Restylane Perlane

Restylane

Active Comparator group

Description:

Single injection and optional touch up injection with Restylane in NLF

Treatment:

Device: Restylane