NCT06336044

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'"

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Taumedika s.r.l. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

The patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.

Conditions

• Wrinkle
• Scar
• Laxity; Skin

Interventions

Type	Name	Description
DEVICE	Karisma	Intradermal injection

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2024-03-28
• Last updated: 2026-01-26

Locations

1 site across 1 country: Italy