Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

NCT03003130 | Completed Results

• 1 other identifier: 43CH1508
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.

Conditions

Nasolabial Folds in Chinese Population

Keywords

Hyaluronic acid; Comparative study; NLF

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.

  The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone

  6 month

Study Arms (2)

Restylane Defyne

EXPERIMENTAL

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

Device: Restylane Defyne

Restylane

ACTIVE COMPARATOR

Single injection and optional touch up injection with Restylane in NLF

Device: Restylane

Interventions

Restylane Defyne DEVICE

Intradermal injection

Restylane Defyne

Restylane DEVICE

Intradermal injection

Restylane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Men or women aged 18 years of age 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 NLFs with a wrinkle severity in WSRS of either 3 on both sides or 4 on both sides, as assessed by the blinded evaluator.

You may not qualify if:

• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) Gel and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics.
• Previous tissue revitalization treatment below the level of the lower orbital rim within 6 months before treatment.
• Previous surgery or tattoo in the area to be treated.
• Previous tissue augmentation therapy or contouring with any permanent (nonbiodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat or permanent implant below the level of the lower orbital rim.
• Previous use of neurotoxins or 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.
• Scars or deformities, active skin disease, inflammation or related conditions such as infection, perioral dermatitis, seborrheic dermatitis, eczema, rosacea, acne, psoriasis, and herpes zoster near or in the area to be treated.
• Other condition preventing the subject from entering the study in the Investigator's opinion

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Q-Med AB

Shanghai, China

Location

Results Point of Contact

• Title: Head of Development
• Organization: Q-Med AB

reception.seupp@galderma.com

+ 46 (0) 18 474 90 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 26, 2016
• Study Start: January 16, 2017
• Primary Completion: March 30, 2018
• Study Completion: September 14, 2018
• Last Updated: November 3, 2023
• Results First Posted: June 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)