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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
Safety objectives
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:
Visit 2 (Day 21 ± 4) and Visit 3 (Day 42 ± 4):
The following activities will be done at Visit 2, and 3:
Visit 4 - End of study (Day 98 ±7):
The following activities will be done at Visit 4:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm for evaluation of the skin hydration modification from baseline to Day 98. | Experimental | Each treatment session will involve multiple microinjections, with needles 30G 4mm, in the face (external corner of the eye and cheek). The amount of product injected will be up to 2 mL, according to Investigator's judgement; the microinjections will be performed at a distance of 1-2 cm from each other. An anesthetic cream could be used before injections, at Investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid injections | Device | Among treatments today available, bio-revitalization is a process which triggers the skin's own, natural collagen production and cell rejuvenation through the injection of hyaluronic acid serums. This substance is hydrophilic, drawing many times its weight in water. As we age, we have less naturally produced HA in our tissues and skin dehydration becomes a telltale sign of aging. The HA owns a great hydrating power, due to this property is widely used in the biorevitalization treatments. Its use results in supple, younger-looking skin with reduced wrinkles and improved elasticity.In bio-revitalization procedures that involve intradermal micro-injections of natural HA, with a molecular weight close to the endogenous one, carried out in correspondence with the imperfections, the viscoelastic properties of HA allow to rehydrate the tissues, allowing to prevent and contrast the aging process skin and promote their remodeling. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The primary endpoint of the study is the change in skin hydration from baseline to Day 98, evaluated through corneometer skin examination. | day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical performance of Foliage Hydrofil in the change of the skin hydration in the treated area at Day 21 42, from baseline | the evaluation of the change in skin hydration from baseline to Day 21 and 42, through corneometer examination. | day 21 - day 42 |
| subject overall satisfaction |
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Inclusion Criteria:
Subjects presenting all the following inclusion criteria will be eligible to enter the study:
Exclusion Criteria:
Subjects presenting one or more of the following exclusion criteria will not be eligible to enter the study:
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| Name | Affiliation | Role |
|---|---|---|
| Tiziana Lazzari | Poliambulatorio di Medicina Estetica Casa della Salute SPA Largo XII Ottobre, 62 16121 GENOVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliambulatorio di Medicina Estetica Casa della Salute SPA, Largo XII Ottobre, 62 | Genova | 16121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40951208 | Derived | Chahine S, Marozzi B, Valle A, Michellini L, Lazzari T. Efficacy and Safety of Non-cross-Linked Hyaluronic Acid Injections for Facial Skin Biorevitalization: A Single-Center, Open-Label, Single-Arm, Uncontrolled, Post-marketing Study. Cureus. 2025 Aug 13;17(8):e90005. doi: 10.7759/cureus.90005. eCollection 2025 Aug. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2022 | Apr 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2023 | Apr 14, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: informed consent | Feb 2, 2022 | May 28, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: information sheet | Feb 2, 2022 | May 28, 2025 | ICF_003.pdf |
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The subject will be asked "Please express your degree of satisfaction with the treatment received" through a 5-points scale (1 very much satisfied, 2 satisfied,3 not satisfied nor unsatisfied, 4 unsatisfied, 5 very unsatisfied). |
| Day 21, 42 and 98 |
| skin texture changement | the investigator will evaluate in his or her own judgment the skin texture as follows: poor-good-very good | Day 21, 42 and 98 |
| Investigator's assessment | the Investigator's aesthetic change assessment using the Global Aesthetic Improvement Scale (GAIS) as follows:
| Day 21, 42 and 98 |
| subject's assessment | the subject's aesthetic change assessment using the Patient's Aesthetic Improvement Scale (PAIS) as follows:
| Day 21, 42 and 98 |
| Smoothing of fine lines | the investigator will evaluate in his or her own judgment the smoothing of fine lines as follows: poor-good-very good | Day 21, 42 and 98 |
| skin tone changement | the investigator will evaluate in his or her own judgment the skin tone as follows: poor-sufficient-middle-good | Day 21, 42 and 98 |
| Wrinkles modification | the investigator will evaluate in his or her own judgment the wrinkles modification as follows:
| Day 21, 42 and 98 |