| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Facial volume loss and dynamic wrinkles of the upper third of the face |
| Perdida de volumen facial y arrugas dinámicas del tercio superior de la cara |
|
| E.1.1.1 | Medical condition in easily understood language |
| Face wrinkles and volume loss |
| Arrugas de la cara y perdida de volumen |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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 |
|
| E.2.2 | Secondary objectives of the trial |
| The efficacy and tolerance will be assessed |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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 |
|
| E.4 | Principal 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) |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Subject satisfaction questionnaire for the full face |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At 3 weeks after the last injection and at last visit |
|
| E.5.2 | 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 |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
For "Efficacy": at each post-baseline visit
For "Other": at each evaluation time |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 6 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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