Evaluation of the Safety and Efficacy of Profhilo® Structura

Launched by IBSA FARMACEUTICI ITALIA SRL · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Profhilo® Structura, which aims to improve the appearance of aging skin. Profhilo® Structura is made from hyaluronic acid, a substance naturally found in the body that helps keep skin hydrated and plump. The trial is looking for healthy men and women between the ages of 35 and 55 who are interested in enhancing their skin's elasticity and restoring lost volume in their faces. To participate, individuals must be in good health, provide informed consent, and agree to keep their skincare routine stable during the study.

Participants can expect to receive the treatment while being monitored by medical professionals throughout the study. It's essential for candidates to meet certain criteria, such as not being pregnant or breastfeeding and avoiding certain medications or treatments that could interfere with the study's results. This trial is currently recruiting participants, and it aims to gather information on both the safety and effectiveness of Profhilo® Structura in treating skin aging.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy subjects
• • 2. Male and Female subjects.
• • 3. Age : between 35 and 55 year
• • 4. Subject having given freely and expressly his/her informed consent obtained according to ISO 14155:2020 and Good Clinical Practice (GCP)
• • 5. Only for treated group: Subject seeking aesthetic improvement for a corrective/filling action of natural and induced skin depressions
• • 6. 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.
• • 7. Subject psychologically able to understand the information related to the investigation including possible risks and side effects.
• • 8. 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.
• • 9. Subject agreeing to keep their usual cleansing / care products during the whole study period.
• • 10. Subject agreeing to apply a SPF50 cream during the whole study period.
• Exclusion Criteria:
• • In terms of population
• • 1. Pregnant or breastfeeding woman or planning a pregnancy during the study.
• • 2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• • 3. Subject in a social or sanitary establishment.
• • 4. Subject enrolled in another study or whose non-enrollment period is not over.
• • 5. For France only: subject having received a total of 6.000 euros as compensations for their participation in the present study.
• • 6. Subject disagrees to keep a stable weight during the study (BMI variation ± 1)
• • 7. Subject with high expectations for the treatment effect.
• • In terms of associated pathology
• • 8. 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
• • 9. Subject with known history of or suffering from autoimmune disease and/or immune deficiency
• • 10. 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
• • 11. Subject with a history of streptococcal disease or an active streptococcus infection
• • 12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• • 13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders
• • 14. Subject having history of severe allergy or anaphylactic shock including known risk of hypersensitivity to one of the components of the composition of the investigational device and to antiseptic solution related to previous or current treatment.
• • 15. Subjects with scar, mole, hair or local skin infection (including viral, bacterial, and fungal); skin granulomas; scar constitution; immune system disorders; presence of active or progressive skin disorders or skin diseases with isomorphic response in the treatment area, such as acute eczema, flat wart, lichen planus, psoriasis vulgaris, etc...
• • 16. Patients with psychiatric disorders or emotional instability.
• • In terms of previous or ongoing treatment or procedure
• • 17. Any medication which may interfere, at the interpretation of the investigator, with the study objectives.
• • 18. Subject having undergone tooth extraction or dental implant procedure within the past 6 weeks or plans to undergo these procedures during the study.
• • 19. Subject having received facial or cervico-facial lifting in the past 24 months or plans to undergo these procedures during the study.
• • 20. Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face within the past 6 months or who plans to undergo any of these procedures during the study.
• • 21. Subject having received within the past 18 months or planning to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., HA, Calcium Hydroxyapatite) or autologous fat on or near the face.
• • 22. Subject having received within the past 9 months or planning to receive during the study any injections outside of those in the study protocol including mesotherapy or botulinum neurotoxin on or near the face.
• • 23. Subject having received at any time or planning to receive a permanent filler on the face (e.g., polylactic acid, Polymethylmethacrylate, silicone) during the study.
• • 24. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).
• • 25. Subject having received in the last 24 months resorbable threads lift on the face.
• • 26. Subject having received at any time injection with unknown products
• • 27. Subject using medication such as aspirin, high dose Vitamin C, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit or being a chronic user.
• • 28. Subject using medication such as narcotic, and immunosuppressive drugs from three weeks before screening visit and during the whole study period
• • 29. Subject having started or stopped an antidepressant 3 weeks prior the study or plans to use it during the study.
• 30. Subject undergoing a topical treatment on the face or a systemic treatment:
• • anti-inflammatory medication and/or antihistamines within the past 2 weeks and during the study,
• • corticosteroids within the past 2 weeks and during the study,
• • retinoids and/or immunosuppressors within the past 3 months and during the study.
• • In terms of lifestyle
• • 31. Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study.
• • 32. Heavy smoker (subject who reports smoking 10 or more cigarettes per day);
• • 33. Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day)