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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-16

Study Completion Date

2018-09-14

Brief Summary

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

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Detailed Description

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Conditions

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Nasolabial Folds in Chinese Population

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Restylane Defyne

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

Group Type EXPERIMENTAL

Restylane Defyne

Intervention Type DEVICE

Intradermal injection

Restylane

Single injection and optional touch up injection with Restylane in NLF

Group Type ACTIVE_COMPARATOR

Restylane

Intervention Type DEVICE

Intradermal injection

Interventions

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Restylane Defyne

Intradermal injection

Intervention Type DEVICE

Restylane

Intradermal injection

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No