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

• Restylane Defyne (Device): Intradermal injection
• Restylane (Device): Intradermal injection

Primary outcomes

• Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS. [6 month]: 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

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Signed informed consent.
2. Men or women aged 18 years of age or older of Chinese origin.
3. 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.
4. 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.

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) Gel and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics.
2. Previous tissue revitalization treatment below the level of the lower orbital rim within 6 months before treatment.
3. Previous surgery or tattoo in the area to be treated.
4. 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.
5. 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.
6. 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.
7. Other condition preventing the subject from entering the study in the Investigator's opinion

Participant flow

Outcome results

• Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS. (Primary), Number, percentage of subjects: Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF 72.9 (66.3 to 79.6); Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF 72.8 (66.1 to 79.5)

Adverse events

Time frame: 1 year.

Serious adverse events by term

• Study Protocol (PDF, 2017-07-05)
• Statistical Analysis Plan (PDF, 2017-02-13)