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
This trial accepts healthy volunteersQualifiers
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 population
Adult of both sexes seeking for a corrective/filling action of natural and induced skin depressions.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Profhilo Structura
Device2 injections (30 days apart) of investigated medical device into superficial fat compartments of zygomatic arch and preauricular area
Sham (No Treatment)
Other interventionSham (No Treatment)
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Treated group1 intervention
Group B: Not treated group1 intervention
Trial outcomes
Primary outcomes
1
Safety endpoint
Number and percentage of subjects with Adverse Device Effects (ADEs) throughout the study.
Time frame
Day 0, Day 30, Day 60, Day 120, Day 180Secondary outcomes
1
Safety endpoint - ISR
Number and percentage of subjects with Injection Site Reaction (ISR) and Adverse Events (AEs).
Time frame
Day 0, Day 30, Day 60, Day 120, Day 1802
Efficacy endpoint - clinical improvement
Percentage of subjects with a clinical improvement from baseline assessed by investigator compared to control group.
Time frame
Day 0, Day 30, Day 60, Day 120, Day 1803
Efficacy endpoint - skin quality
Percentage of subjects with a skin quality improvement using Beagley-Gibson surface microrelief scale (from grade 1 \[Mild\] to grade 4 \[Severe\] from baseline as assessed by investigator compared to control group.
Time frame
Day 0, Day 30, Day 60, Day 120, Day 1804
Efficacy endpoint - satisfaction
Percentage of positive responders (rated 3 or less) on the GAIS (from grade 1 \[Very much improved\] to grade 5 \[Worse\] as assessed by investigator and subjects in live.
Time frame
Day 0, Day 30, Day 60, Day 120, Day 180Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IBSA Farmaceutici Italia Srl
Lead sponsor
Eurofins Dermscan Pharmascan
Collaborator
IBSA Institut Biochimique SA
Collaborator
Source ClinicalTrials.gov