Actively Recruiting
Prospective, Multicentric, Controlled Clinical Investigation to Evaluate the Safety and Efficacy of Profhilo® Structura for Facial Adipose Tissue Restoration in Adults Aged 35 to 55
Led by IBSA Farmaceutici Italia Srl · Updated on 2024-12-05
164
Participants Needed
3
Research Sites
26 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
Researchers are evaluating Profhilo® Structura, an injectable product made from high and low molecular weight hyaluronic acid (HA), for restoring facial adipose tissue and improving skin volume loss in adults aged 35 to 55. This product is designed to combat the natural decrease of HA in the skin, enhancing hydration, elasticity, and skin tone to address mild-to-moderate facial volume loss and acne scars. The trial is a prospective, multicenter, controlled, double-arm clinical investigation sponsored by IBSA Farmaceutici Italia Srl. Participants in the study are divided into two groups: one treated group receiving two injections of Profhilo® Structura spaced 30 days apart into superficial fat compartments of the face, and a non-treated control group. The product's unique rheological properties allow higher concentrations of HA to be administered with good tolerability, aiming to restore adipose tissue and improve skin laxity by spreading and integrating into the fat tissue. During the study, participants will be monitored on days 0, 30, 60, 120, and 180 for safety and efficacy outcomes, including clinical improvement, skin quality, satisfaction, and instrumental measures. Assessments will include safety endpoints and injection site reactions. Participants are expected to maintain their usual skincare routines and apply SPF50 sunscreen throughout the study. The total study duration per participant is approximately six months, with regular follow-up visits to evaluate treatment effects and safety.
CONDITIONS
Brief Title
Evaluation of the Safety and Efficacy of Profhilo® Structura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female adults aged 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 or induced skin depressions
- Women of childbearing potential must have a negative pregnancy test and use reliable contraception throughout the study
- Psychologically able to understand study information and comply with study visits
- Agree to maintain usual skincare products and apply SPF50 sunscreen during the study period
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Under legal guardianship or deprived of freedom
- Residing in social or sanitary establishments
- Enrolled in another study or within a non-enrollment period
- For France only: received compensation of 6,000 euros for study participation
- Unwilling to keep stable weight during the study (BMI variation ±1)
- Having high expectations for treatment effect
- Suffering from severe or progressive diseases, autoimmune or immune deficiency disorders
- Active infections or inflammatory skin conditions within 6 months before screening
- History of streptococcal disease or active streptococcus infection
- Prone to inflammatory skin conditions, bleeding disorders, keloids, or poor healing
- History of severe allergies or anaphylactic shock including hypersensitivity to device components
- Presence of scars, moles, infections, granulomas, or active skin diseases in treatment area
- Psychiatric disorders or emotional instability
- Using medications interfering with study objectives
- Recent or planned dental extractions or implants within 6 weeks
- Previous facial lifting within 24 months or planned during study
- Recent facial treatments like laser, dermabrasion, chemical peels within 6 months
- Prior injections of fillers or botulinum toxin within specified timeframes
- Presence of facial implants, threads, or unknown injected products
- Use of aspirin, NSAIDs, anticoagulants, narcotics, immunosuppressants, or antidepressants within specified periods
- Recent topical or systemic treatments affecting skin within specified periods
- Intensive sun or UV exposure within the previous 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants in the treated group receive 2 injections of Profhilo Structura into superficial fat compartments of the zygomatic arch and preauricular area, 30 days apart. Participants in the not treated group do not receive treatment but are observed.
2 injection visits (in-person) spaced 30 days apart
Duration - Approximately 5 months after last injection
Participants are monitored for safety and efficacy outcomes including clinical improvement, skin quality, satisfaction, and instrumental improvement over a 6-month period.
4 follow-up visits (in-person) at Day 60, Day 120, and Day 180 after first injection
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
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
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