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Evaluation of the Safety and Efficacy of Profhilo® Structura

NCT06719154 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2024-12-05

No results posted yet for this study

Summary

Profhilo® Structura is composed of a buffered saline solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high- and low-molecular-weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes; this results in excellent tolerability of the product.

In addition, the HA chains with different molecular weight present in Profhilo® Structura, thanks to a specific and patented treatment of the solution (NAHYCO® Hybrid Technology), interact with each other, giving Profhilo® Structura unique rheological properties that allow higher concentrations of HA to be administered at equal viscosity of the solution.

The formulation based on HA with different molecular weight contained in Profhilo® Structura is based on the Hydrolift® Action system, the innovative approach aimed at combating the physiological decrease of HA in the skin, restoring hydration, elasticity and tone, synergistically associating deep hydration with the mechanical lifting action of the skin depression.

Thanks to its rheological properties and cohesivity Profhilo® Structura is able to optimally spread and integrate into the interstitial spaces of the adipose tissue. Profhilo® Structura has the specific indication for adipose tissue restoration and is able to counteract facial volume loss.

Conditions

  • Skin Aging

Interventions

DEVICE

Profhilo Structura

2 injections (30 days apart) of investigated medical device into superficial fat compartments of zygomatic arch and preauricular area

OTHER

Sham (No Treatment)

Sham (No Treatment)

Sponsors & Collaborators

  • Eurofins Dermscan Pharmascan

    collaborator INDUSTRY

  • IBSA Institut Biochimique SA

    collaborator INDUSTRY

  • IBSA Farmaceutici Italia Srl

    lead INDUSTRY

Principal Investigators

  • Izabela Błażewicz, MD · Eurofins Dermscan Poland

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • France
  • Poland

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 NCT06719154 on ClinicalTrials.gov