RecruitingNot ApplicableNCT06336044

Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'

"Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'"


Sponsor

Taumedika s.r.l.

Enrollment

40 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • all sexes
  • caucasic
  • to 70 years
  • non smoker

Exclusion Criteria10

  • 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

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Interventions

DEVICEKarisma

Intradermal injection


Locations(1)

Ospedale Tor Vergata

Roma, Italy

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NCT06336044


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