Evaluation of the Safety and Efficacy of Profhilo® Structura

NCT06719154 | Recruiting

• 1 other identifier: 23E3318
• Study Type: observational
• Target: 164
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

aging; adipose tissue

Outcome Measures

Primary Outcomes (1)

• Safety endpoint

  Number and percentage of subjects with Adverse Device Effects (ADEs) throughout the study.

  Day 0, Day 30, Day 60, Day 120, Day 180

Secondary Outcomes (5)

• Safety endpoint - ISR

  Day 0, Day 30, Day 60, Day 120, Day 180

• Efficacy endpoint - clinical improvement

  Day 0, Day 30, Day 60, Day 120, Day 180

• Efficacy endpoint - skin quality

  Day 0, Day 30, Day 60, Day 120, Day 180

• Efficacy endpoint - satisfaction

  Day 0, Day 30, Day 60, Day 120, Day 180

• Efficacy endpoint - instrumental improvement

  Day 0, Day 30, Day 60, Day 120, Day 180

Study Arms (2)

Treated group

120 subjects will be treated Healthy subjects Male and Female subjects. Age : between 35 and 55 year

Device: Profhilo Structura

Not treated group

44 subjects will be not treated Healthy subjects Male and Female subjects. Age : between 35 and 55 year

Other: Sham (No Treatment)

Interventions

Profhilo Structura DEVICE

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

Treated group

Sham (No Treatment) OTHER

Sham (No Treatment)

Not treated group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult of both sexes seeking for a corrective/filling action of natural and induced skin depressions.

You may qualify if:

• 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
• 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.
• Subject agreeing to keep their usual cleansing / care products during the whole study period.
• Subject agreeing to apply a SPF50 cream during the whole study period.

You may not qualify if:

• In terms of population
• 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.
• In terms of associated pathology
• 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
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency
• Subject suffering from active disease such as inflammation, infection, tumour, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria…) in the 6 months before screening visit
• Subject with a history of streptococcal disease or an active streptococcus infection
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• Subject predisposed to keloids or hypertrophic scarring or having healing disorders

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead
• Eurofins Dermscan Pharmascan: collaborator
• IBSA Institut Biochimique SA: collaborator

Study Sites (3)

Eurofins Dermscan Pharmascan

Villeurbanne, Lyon, 69100, France

RECRUITING

Eurofins Dermscan Poland

Gdansk, 80-288, Poland

NOT YET RECRUITING

Aesthetic clinical

Poznan, 80-288, Poland

NOT YET RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Izabela Błażewicz, MD

  Eurofins Dermscan Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilberto Bellia

CONTACT

+39 71617360; g.bellia@ibsa.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: December 5, 2024
• Study Start: September 9, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

FR (1); PL (2)