Facial volume loss and dynamic wrinkles of the upper third of the face MedDRA version: 14.0 Level: PT Classification code 10040954 Term: Skin wrinkling System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Azzalure®
Product Name: Azzalure®
Product Code: Not applicable
Pharmaceutical Form: Powder for solution for injection
Trade Name: Restylane®
Product Name: Restylane®
Product Code: NA
Phar
Sponsors
Galderma R&D
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Secondary Objective: The efficacy and tolerance will be assessed;Primary end point(s): Subject’s satisfaction: - Subject satisfaction questionnaire for the full face, 3 weeks after the last injection and at last visit ;Timepoint(s) of evaluation of this end point: At 3 weeks after the last injection and at last visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Investigator’s global aesthetic improvement from baseline for the full face, using a scale from -1 (worse) to 3 (very much improved), - Subject’s global aesthetic improvement from baseline for the full face, using a scale from -1 (worse) to 3 (very much improved), - Investigator’s lifting effect assessment for the full face using a scale from 0 (Worsening) to 4 (Extremely effective), The investigator will also assess at each study visit (only for treated indications): - Wrinkle severity, at rest and at maximum contraction, using a scale from 0 (none) to 3 (severe) for forehead wrinkles, lateral canthal lines and glabellar lines - Wrinkle severity using the Lemperle Rating Scale: 0 (no wrinkles) to 5 (very deep wrinkle, redundant fold), for nasolabial folds, marionettes lines, upper lip lines and cheekfolds - Lip enhancement using the Lip Fullness Grading Scale: 0 (very thin lip) to 4 (full lip) - Tear trough depth assessment (in millimeter) - Indication aesthetic improvement from baseline using a scale from -1 (worse) to 3 (very much improved) for cheeks, cheekbones, chin and jawline - Microrelief assessment, using a scale from 0 to 4, for indications treated with Azzalure® only - Pore size assessment, using a scale from 0 to 5, for indications treated with Azzalure® only - Other: - Subject quality of life questionnaire using the WHO-5 questionnaire, - Subject self-esteem state measurement using the Heatherton & Polivy State Self-Esteem (HPSS) scale, - Photographs - An external and independent board will assess the photographs in terms of: . lifting effect . perceived age . first impression Safety: - Adverse Events, as reported by the investigator ;Timepoint(s) of evaluation of this end point: For "Efficacy": at each post-baseline visit For "Other": at each evaluation time | — |
Countries
Spain, United Kingdom
Contacts
Public ContactPaliargues
Galderma R&D
Outcome results
None listed