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

NCT07010549 | Completed

• 1 other identifier: FOLIAGE-2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Ageing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• clinical performance of Foliage Hydrofil in the change of the skin hydration in the treated area at Day 21 42, from baseline

  day 21 - day 42

• subject overall satisfaction

  Day 21, 42 and 98

• skin texture changement

  Day 21, 42 and 98

• Investigator's assessment

  Day 21, 42 and 98

• subject's assessment

  Day 21, 42 and 98

Study Arms (1)

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.

Device: Hyaluronic Acid injections

Interventions

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.

single arm for evaluation of the skin hydration modification from baseline to Day 98.

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy man and women, aged between 30 and 55 years (inclusive), looking for aesthetic procedures to improve the aspect of their face.
• Caucasian race (skin type from I to IV as per Fitzpatrick Skin Type scale)
• 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;
• Corneometer Capacitance of the area treated \< 80
• Subjects wishing not to modify their lifestyle during the study period;
• 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;
• Written informed consent release prior to any study-related procedures. -

You may not qualify if:

• Pregnancy or breastfeeding woman or woman of childbearing potential not practicing adequate contraception.
• Subjects with Fitzpatrick skin type from V to VI
• Subjects with known allergy/hypersensitivity to product components.
• Extensively photo damaged and aged skin according to the Investigators opinion.
• Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face, hands or décolletage.
• Immune system disorders
• History of or active collagenosis (e.g. systemic lupus, erythematosis, rheumatic arthritis, skin or systemic sclerosis).
• Concomitant therapy with thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, within 2 weeks before the first product administration.
• History of cancerous or pre-cancerous lesions in the face, neck and décolletage.
• Tattoo/s on the skin around the treatment site
• 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.
• Use of injectable revitalization preparations within 12 months prior to the baseline visit.
• Use of retinoic acid within 6 months prior to the baseline visit.
• Previous or concomitant treatment with chemotherapy, immunosuppressive agents or corticoids.
• History of treatment with permanent filling materials.

Sponsors & Collaborators

• Phitogen Beauty Labs SRL: lead

Study Sites (1)

Poliambulatorio di Medicina Estetica Casa della Salute SPA, Largo XII Ottobre, 62

Genova, 16121, Italy

Location

Related Publications (1)

• 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.

  PMID: 40951208 DERIVED

Study Officials

• Tiziana Lazzari

  Poliambulatorio di Medicina Estetica Casa della Salute SPA Largo XII Ottobre, 62 16121 GENOVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: June 8, 2025
• Study Start: September 27, 2022
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

IT (1)