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Recruiting
NCT06336044
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
Conditions: Wrinkle, Scar, Laxity; Skin
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Taumedika s.r.l.
Location: Ospedale Tor Vergata Roma
Summary
Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events
Eligibility Criteria
Inclusion Criteria:
* all sexes
* caucasic
* 18 to 70 years
* non smoker
Exclusion Criteria:
* Pregnancy
* milking
* smoker
* alcohol or drugs abuse
* change of BMI during the study
* previous facial surgery, implants, permanent treatments
* sensitivity to the product
* dermatological difficult frame
* health weakness
* treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results
Source: ClinicalTrials.gov (NCT06336044). StuddyBuddy aggregates publicly available trial information.