Subjects’ satisfaction on pan facial aesthetic enhancement after treatment with Azzalure® and the Restylane® range

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Male or female subject aged 18 to 64 years inclusive (as much as possible, one third of male subjects)
2. Subject seeking treatment for correction of facial volume loss (mid and lower face) for at least two indications and correction of dynamic wrinkles of the upper third of the face for at least one indication
3. Female subject of childbearing potential must have a negative urinary pregnancy test (UPT) at the beginning of the study and at the last visit and must practice an effective method of contraception during the study: oral/systemic [injectable, patch…] contraception, intrauterine device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy
4. Female of non-childbearing potential, eg: premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility is not required to have a UPT at the beginning of the study
5. Subject willing and capable of cooperating to the extend and degree required by the protocol, including face photographs
6. Subject having read and signed the approved Informed Consent Form prior to any participation in the study

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Female subject who is pregnant, nursing or planning a pregnancy during the study
2. Subject with a wash-out period for procedure(s)/treatment(s) on the face less than (see table below):
• Retinoids, microdermabrasion or chemical peels: 2 weeks
• Non-ablative light treatments (e.g. Intense Pulsed Light, light-emitting diodes): 1 month
• Ablative skin resurfacing: 3 months
• Non-ablative dermal treatment for skin tightening (e.g. radio-frequency treatments): 3 months
• Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic acid
preparations): 6 months
• Treatment with a BoNT-A: 6 months
3. Subject who underwent a surgical facelift
4. Permanent dermal fillers in the face
5. Current facial palsy
6. Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis)
7. Subject with history of autoimmune diseases
8. Subject with history of bleeding disorders or who have received substances that reduce coagulation as anticoagulant treatment including aspirin, antiplatelet treatment, non-steroidal anti-inflammatory within 7 days prior to baseline visit
9. Subject with a history of severe keloids and/or hypertrophic scars on the face
10. Subject with any contraindications to the injection of hyaluronic acid (see package inserts)
11. Subject with any contraindications to the injection of botulinum toxin (see package insert)
12. Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin
13. Concurrent use of treatments that affects neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics
14. 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
15. Subject who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...)
16. Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations
17. Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit
18. Vulnerable subject as defined in section 1.61.of ICH Guideline for Good Clinical Practice and section 3.44 of the revised ISO 14155:2011 (version 2011-02)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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<br><br><br>;Secondary Objective: The efficacy and tolerance will be assessed;Primary end point(s): Subject’s satisfaction:<br>- Subject satisfaction questionnaire for the full face, 3 weeks after the last injection and at last visit<br><br>;Timepoint(s) of evaluation of this end point: At 3 weeks after the last injection and at last visit

Secondary Outcome Measures

Name	Time	Method

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