Evaluation of the Safety and Efficacy of Profhilo® Structura

ConditionSkin Aging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-55
SponsorIBSA Farmaceutici Italia Srl

About this trial

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.

Eligibility criteria

Qualifiers

Healthy subjects

Male and Female subjects.

Age : between 35 and 55 year

Subject having given freely and expressly his/her informed consent obtained according to ISO 14155:2020 and Good Clinical Practice (GCP)

Disqualifiers

Pregnant or breastfeeding woman or planning a pregnancy during the study.

Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.

Subject in a social or sanitary establishment.

Subject enrolled in another study or whose non-enrollment period is not over.

Trial design

Treatments tested in this trial

  • Profhilo Structura
  • Sham (No Treatment)

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IBSA Farmaceutici Italia Srl

Lead sponsor

Eurofins Dermscan Pharmascan

Collaborator

IBSA Institut Biochimique SA

Collaborator