Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-09-28

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intradermal injection

Restylane and/or Perlane

Group Type EXPERIMENTAL

Restylane

Intervention Type DEVICE

Facial tissue augmentation

Perlane

Intervention Type DEVICE

Facial tissue augmentation

Interventions

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Restylane

Facial tissue augmentation

Intervention Type DEVICE

Perlane

Facial tissue augmentation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects intent to undergo facial filler treatment for either volume loss or contouring
* Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin)
* Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance
* Facial appearance as Han Chinese
* Non-pregnant, non-breast feeding female
* Signed informed consent

Exclusion Criteria

* Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated.
* History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose).
* Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose).
* Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area.
* Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment.
* Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
* Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
* Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
* Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes