Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds

Galderma

Status: Completed

Conditions: Nasolabial Fold

Treatments: Device: Restylane Perlane; Device: Restylane Perlane Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03174132

43TW1628

Details and patient eligibility

About

The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale

Enrollment: 70 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent to participate in the study.
• Men or women aged 20 years or older of Chinese origin.
• Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.
• Intent to undergo correction of both nasolabial folds (NLF) with a wrinkle severity in Wrinkle Severity Rating Scale (WSRS) of either grade 3 on both NLFs or grade 4 on both NLFs.

Exclusion criteria

• Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
• Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.
• Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the midface within 6 months before treatment.
• Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated.
• Other condition preventing the subject from entering the study in the Investigator's opinion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Restylane Perlane Lidocaine

Experimental group

Description:

Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1

Treatment:

Device: Restylane Perlane Lidocaine

Restylane Perlane

Active Comparator group

Description:

Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1

Treatment:

Device: Restylane Perlane