Evaluation of the Safety and Efficacy of Profhilo® Structura (NCT06719154) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Safety and Efficacy of Profhilo® Structura
France, Poland164 participantsStarted 2024-09-09
Plain-language 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.
Who can participate
Age range35 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. Only for treated group: Subject seeking aesthetic improvement for a corrective/filling action of natural and induced skin depressions
✓. Women of childbearing potential must have a negative urine pregnancy test result at inclusion visit and must use a reliable method of contraception since at least 12 weeks and throughout the study.
✓. Subject psychologically able to understand the information related to the investigation including possible risks and side effects.
✓. Subject able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.
Exclusion criteria
What they're measuring
1
Safety endpoint
Timeframe: Day 0, Day 30, Day 60, Day 120, Day 180
✕. 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.
✕. For France only: subject having received a total of 6.000 euros as compensations for their participation in the present study.
✕. Subject disagrees to keep a stable weight during the study (BMI variation ± 1)
✕. Subject with high expectations for the treatment effect.
✕. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety