Actively Recruiting
Evaluation of the Safety and Efficacy of Profhilo® Structura
Led by IBSA Farmaceutici Italia Srl · Updated on 2024-12-05
164
Participants Needed
3
Research Sites
64 weeks
Total Duration
On this page
Sponsors
I
IBSA Farmaceutici Italia Srl
Lead Sponsor
E
Eurofins Dermscan Pharmascan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Safety and Efficacy of Profhilo® Structura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female subjects
- Age between 35 and 55 years
- Provided informed consent according to ISO 14155:2020 and Good Clinical Practice
- For treated group: seeking aesthetic improvement for natural and induced skin depressions
- Women of childbearing potential must have a negative pregnancy test and use reliable contraception for 12 weeks before and during the study
- Psychologically able to understand study information and risks
- Able to cooperate with investigators and comply with study visits
- Agree to maintain usual skin cleansing and care products during the study
- Agree to apply SPF50 cream throughout the study period
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Deprived of freedom by legal decision or under guardianship
- Residing in social or sanitary institutions
- Participating in another study or within non-enrollment period
- (France only) Received 6,000 euros compensation for this study
- Unwilling to maintain stable weight (BMI variation �� 1)
- Having unrealistic treatment expectations
- Severe or progressive diseases, autoimmune or immune deficiency disorders
- Active infections, inflammation, tumors, or skin disorders in treatment area within 6 months
- History or active streptococcal disease or infection
- Prone to inflammatory skin conditions, bleeding disorders, or poor healing
- History of severe allergy or hypersensitivity to device components or antiseptics
- Presence of scars, moles, infections, granulomas, or immune system disorders in treatment area
- Psychiatric disorders or emotional instability
- Use of medications interfering with study objectives
- Recent or planned dental extractions or implants within 6 weeks
- Facial or cervico-facial lifting within 24 months or planned
- Laser, ultrasound, radiofrequency, dermabrasion, surgery, chemical peeling within 6 months or planned
- Injections with fillers, mesotherapy, botulinum toxin, or permanent fillers within specified time frames or planned
- Subcutaneous retaining structures or threads on face
- Use of aspirin, NSAIDs, anticoagulants within 1 week prior or chronic use
- Use of narcotics, immunosuppressive drugs 3 weeks prior and during the study
- Recent start or plan to use antidepressants
- Use of anti-inflammatory, corticosteroids, antihistamines, retinoids, or immunosuppressors within specified periods
- Intensive sun or UV exposure within 1 month or planned
- Heavy smoking (10 or more cigarettes per day)
- Excessive alcohol consumption (more than 2 glasses of wine per day)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Eurofins Dermscan Pharmascan
Villeurbanne, Lyon, France, 69100
Actively Recruiting
2
Eurofins Dermscan Poland
Gdansk, Poland, 80-288
Not Yet Recruiting
3
Aesthetic clinical
Poznan, Poland, 80-288
Not Yet Recruiting
Research Team
G
Gilberto Bellia
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here