Evaluation of the Safety and Efficacy of Profhilo® Structura

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.

NCT Number	NCT06719154
Lead Sponsor	IBSA Farmaceutici Italia Srl Collaborators: Eurofins Dermscan Pharmascan, IBSA Institut Biochimique SA
Conditions	Skin Aging
Enrollment	164 participants
Start Date	2024-09-09
Primary Completion	2025-06 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-12-05