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

Study Overview
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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.

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

Conditions
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Aging

Intervention / Treatment
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* Drug: Botulinum Toxin Type A (Azzalure)
* Device: Restylane ranges


Participation Criteria
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Eligibility Criteria
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Main 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 Main 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Azzalure and Restylane<br>All subjects will be injected with Azzalure and Restylane | Drug: Botulinum Toxin Type A (Azzalure)<br>* Powder for solution for injection<br>Device: Restylane ranges<br>* Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction for the Full Face | based on the subject's satisfaction questionnaire | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement From Baseline | The scale responses are: -1 indicating worse, 0 indicating no change, 1 indicating improved, 2 indicating much improved and 3 indicating very much improved. | Week 3 | 
| Related Adverse Event | Number of subjects reporting related adverse events | Month 6 |