Clinical and Instrumental Evaluation of the Face Biorevitalization Effect With the Medical Device Foliage Hydrofil

Clinical and Instrumental Evaluation of the Face Biorevitalization Effect With the Medical Device Foliage Hydrofil

this is a Post market, prospective, single arm, clinical investigation. Foliage Hydrofil is a CE marked, class III, resorbable medical device (sterile, non-pyrogenic and physiological gel) to be used for the hydration of the skin and for the correction of superficial skin imperfections of the face and body and in the process of repairing the dermal tissue. The main component of Foliage Hydrofil is HA sodium salt of non-animal origin, produced by bacterial fermentation. Each subject will receive three treatments, one vial 2mL (1.6% HA formulation) each, with Foliage Hydrofil, 3 weeks apart. Foliage Hydrofil will be injected with needles 30G 4mm only. The area treated with the study treatment will be the face. The device administration could be done after an anesthetic cream application, according to Investigator's judgement.

Primary objective

• To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area (face) at Day 98, from baseline. Secondary objectives
• To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area at Day 21 and 42, from baseline;
• To evaluate the improvement of the skin texture, skin tone, smoothing of fine lines and wrinkles in the treated area at Day 21, 42 and 98, from baseline;
• To evaluate the aesthetic change from baseline as judged by the Investigator at Day 21, 42 and 98;
• To evaluate the aesthetic change from baseline as judged by the subject at Day 21, 42 and 98;
• To evaluate the subject's satisfaction at Day 21, 42 and 98

Safety objectives

• To assess the local safety at injection site (pain, erythema, edema, bruising) of the treatment with Foliage Hydrofil;
• To assess the systemic safety of the treatment with Foliage Hydrofil.

Study Visits and Assessments

Visit 1 screening - baseline- treatment start (day 1):

Subjects will be evaluated with regard to the inclusion and exclusion criteria that will allow their participation into the study. Before any study specific evaluation is carried out, subjects will receive all the information about the study by the Investigator and will sign an informed consent form.

The following activities will be performed at first visit:

• Collection of demographic information
• Medical and surgical history
• Physical examination (focused on the skin)
• Previous (in the 30 days before) and concomitant medications / treatments recording
• Urine pregnancy test (where applicable)
• Inclusion/exclusion criteria assessment
• Photos of the treated area (before injections)
• Corneometer examination of treated area (before injections)
• Skin surface characteristics, texture, tone, fine lines and wrinkles (before injections)
• First treatment
• Local and systemic adverse events after the first treatment. The following treatment session will be scheduled three weeks later, with a window of ± 4 days. The subject will be solicited to contact the Investigator for any problem between visits.

Visit 2 (Day 21 ± 4) and Visit 3 (Day 42 ± 4):

The following activities will be done at Visit 2, and 3:

• Physical examination (focused on the skin)
• Change in concomitant medications / treatments recording
• Photos of the treated area (before second/third injection session)
• Corneometer examination of treated area (before second/third injection session)
• Skin surface characteristics, texture, tone, fine lines and wrinkles (before second/third injection session)
• PAIS Subject
• GAIS Investigator
• Second/third treatment
• Adverse events (occurred since previous visit) recording
• Local and systemic adverse events after the second/third treatment. The second and third treatment sessions will be scheduled three weeks apart from each other, with a window of ± 4 days. The subject will be solicited to contact the Investigator for any problem between visits. The final visit will be scheduled about 2 months after last treatment session.

Visit 4 - End of study (Day 98 ±7):

The following activities will be done at Visit 4:

• Physical examination (focused on the skin)
• Change in concomitant medications / treatments recording
• Photos of the treated area
• Corneometer examination of treated area
• Skin surface characteristics, texture, tone, fine lines and wrinkles
• PAIS Subject
• GAIS Investigator
• Overall satisfaction by subject
• Adverse events (occurred since previous visit) recording. Should the subject interrupt or conclude in advance the clinical study, for any reason, a Visit 4 will be completed

Inclusion Criteria:

Subjects presenting all the following inclusion criteria will be eligible to enter the study:

1. Generally healthy man and women, aged between 30 and 55 years (inclusive), looking for aesthetic procedures to improve the aspect of their face.
2. Caucasian race (skin type from I to IV as per Fitzpatrick Skin Type scale)
3. Visible signs of skin aging in the face (e.g. reduced skin elasticity, reduced turgor, actinic elastosis, smaller and larger wrinkles) according to the Investigators opinion;
4. Corneometer Capacitance of the area treated < 80
5. Subjects wishing not to modify their lifestyle during the study period;
6. Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks, side effects and discomforts and willing to adhere to the study schedule (including attendance to the planned visits) and study prescriptions;
7. Written informed consent release prior to any study-related procedures. -

Exclusion Criteria:

Subjects presenting one or more of the following exclusion criteria will not be eligible to enter the study:

1. Pregnancy or breastfeeding woman or woman of childbearing potential not practicing adequate contraception.
2. Subjects with Fitzpatrick skin type from V to VI
3. Subjects with known allergy/hypersensitivity to product components.
4. Extensively photo damaged and aged skin according to the Investigators opinion.
5. Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face, hands or décolletage.
6. Immune system disorders
7. History of or active collagenosis (e.g. systemic lupus, erythematosis, rheumatic arthritis, skin or systemic sclerosis).
8. Concomitant therapy with thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, within 2 weeks before the first product administration.
9. History of cancerous or pre-cancerous lesions in the face, neck and décolletage.
10. Tattoo/s on the skin around the treatment site
11. Previous tissue augmenting therapy with non-permanent filler or treatment with botulinum toxin, aesthetic surgical therapy, laser treatment, mesotherapy, or any form of peeling in the face, hands or décolletage within 12 months prior to the baseline visit.
12. Use of injectable revitalization preparations within 12 months prior to the baseline visit.
13. Use of retinoic acid within 6 months prior to the baseline visit.
14. Previous or concomitant treatment with chemotherapy, immunosuppressive agents or corticoids.
15. History of treatment with permanent filling materials.
16. Participation in any other clinical study within 30 days prior to the first visit or plan to participate in another clinical study during this study period.
17. Planned or ongoing weight reduction program during the study.
18. Known history of drug or alcohol abuse within 6 months prior to the baseline visit.
19. Known hypersensitivity to one or more components of anesthetic creams
20. Nicotine use during the study or stopped within 12 months before the first visit.
21. Any medical condition that in the opinion of the Investigator makes the subject unsuitable for inclusion (e.g. severe chronic disease, malignancy, bleeding disorder, skin diseases etc).
22. Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects anticipated to be unreliable, unable to return for the follow-up visits, not likely to avoid other prohibited treatments or procedures or incapable of understanding the information or instructions. -