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

NCT07010549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-08

No results posted yet for this study

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

Interventions

DEVICE

Hyaluronic Acid injections

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.

Sponsors & Collaborators

  • Phitogen Beauty Labs SRL

    lead INDUSTRY

Principal Investigators

  • Tiziana Lazzari · Poliambulatorio di Medicina Estetica Casa della Salute SPA Largo XII Ottobre, 62 16121 GENOVA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2023-02-09
Completion
2023-02-09

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010549 on ClinicalTrials.gov