"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'"

NCT06336044 NA RECRUITING

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

Details

Lead sponsor	Taumedika s.r.l.
Phase	NA
Status	RECRUITING
Enrolment	40
Start date	2026-02
Completion	2026-06

Conditions

• Wrinkle
• Scar
• Laxity; Skin

Interventions

• Karisma

Primary outcomes

• Safety: no adverse events — 16 weeks
  test the safety of the device evaluating any potential adverse event
• Efficacy: change of wrinkles and scars — 16 weeks
  test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale
• Efficacy: change of wrinkles and scars — 16 weeks
  test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)
• Efficacy: change of wrinkles and scars — 16 weeks
  test the efficacy of the device measuring the skin surface evaluating the face volume
• Efficacy: change of wrinkles and scars — 16 weeks
  test the efficacy of the device measuring the skin surface with skin hydratation measurement

Countries

Italy