Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds

NCT04174131 | Completed Phase 3

• 1 other identifier: 2019-Gal-004NLF
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF).

Conditions

Wrinkles Such as Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Skin lifting capacity of two Restylane products, as assessed by ultrasound

  The lifting capacity of two Restylane products (i.e., Restylane + Lidocaine and Restylane Lyft) will be assessed post-injection, using a skin ultrasound.

  Baseline

Secondary Outcomes (1)

• Skin lifting capacity of two Restylane products, as assessed by ultrasouns

  Week 2

Study Arms (2)

Treatment A (right) B (left)

EXPERIMENTAL

Subjects will receive Restylane + Lidocaine and Restylane Lyft. One product will be randomized, per NLF.

Device: Restylane + Lidocaine; Device: Restylane® Lyft

Treatment B (right) A (left)

EXPERIMENTAL

Subjects will receive Restylane + Lidocaine and Restylane Lyft. One product will be randomized, per NLF.

Device: Restylane + Lidocaine; Device: Restylane® Lyft

Interventions

Restylane + Lidocaine DEVICE

Restylane + Lidocaine is a HA gel generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. It is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.

Treatment A (right) B (left); Treatment B (right) A (left)

Restylane® Lyft DEVICE

Restylane® Lyft is a sterile gel of HA with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation (Galderma Laboratories, 2014).

Treatment A (right) B (left); Treatment B (right) A (left)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of consent, women between the ages of 30 and 75 years old;
• Indication for treatment of bilateral NLFs and wrinkles;
• Willingness to comply with study requirements;
• Provide written consent;
• Accepted the obligation not to receive any other facial procedures through the follow-up;
• Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
• No previous facial fillers for a period of 12 months prior to this study;
• No previous facial fillers in the complete region of the NLF for 18 months prior to this study

You may not qualify if:

• Current pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\];
• Hypersensitivity to hyaluronic acid or local anesthetics;
• Patients meeting any official Restylane contra-indications;
• Patients presenting with porphyria;
• Inability to comply with follow-up and abstain from facial injections during the study period;
• Heavy smokers, classified as smoking more than 12 cigarettes per day;
• History of severe or multiple allergies manifested by anaphylaxis;
• Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
• Previous maxillofacial surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
• History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
• Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area;
• Cancer or precancer in the treatment area, e.g. actinic keratosis;
• History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs \[NSAIDs\]), within 2 weeks before treatment;
• Patients using immunosuppressants;
• Patients with a tendency to form hypertrophic scars or any other healing disorders;

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc

Montreal, Quebec, H3R 3A1, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: November 13, 2019
• Primary Completion: December 12, 2019
• Study Completion: February 12, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

CA (1)