Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range

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

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-04-30

Brief Summary

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The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.

This will be an open, multi-centre study.

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Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Azzalure and Restylane

All subjects will be injected with Azzalure and Restylane

Group Type OTHER

Botulinum Toxin Type A (Azzalure)

Intervention Type DRUG

Powder for solution for injection

Restylane ranges

Intervention Type DEVICE

Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)

Interventions

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Botulinum Toxin Type A (Azzalure)

Powder for solution for injection

Intervention Type DRUG

Restylane ranges

Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria

Exclusion Criteria

* Female subject who is pregnant, nursing or planning a pregnancy during the study
* Subject with any contraindications to the injection of hyaluronic acid (see package inserts)
* Subject with any contraindications to the injection of botulinum toxin (see package insert)
* Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin
* Concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments
* Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations
* Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No