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

Galderma

Status: Completed

Conditions: Nasolabial Folds in Chinese Population

Treatments: Device: Restylane; Device: Restylane Defyne

Study type: Interventional

Funder types: Industry

Identifiers

NCT03003130

43CH1508

Details and patient eligibility

About

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

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

175 participants in 2 patient groups

Restylane Defyne

Experimental group

Description:

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

Treatment:

Device: Restylane Defyne

Restylane

Active Comparator group

Description:

Single injection and optional touch up injection with Restylane in NLF

Treatment:

Device: Restylane