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

Galderma

Status: Completed

Conditions: Nasolabial Fold

Treatments: Device: Restylane; Device: Restylane Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02918721

43CH1504

Details and patient eligibility

About

The purpose of this study is to evaluate the pain and safety associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Men or women aged 18 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 3 on both sides or 4 on both sides

Exclusion criteria

• Previous use of any permanent (non-biodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat 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 revitalisation treatment with laser or light, mesotherapy radiofrequency, 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

---

70 participants in 2 patient groups

Restylane Lidocaine

Experimental group

Description:

Restylane Lidocaine will be injected into one side nasolabial fold on Day 1

Treatment:

Device: Restylane Lidocaine

Restylane

Active Comparator group

Description:

Restylane will be injected into the opposite side nasolabial fold on Day 1

Treatment:

Device: Restylane