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

Not Applicable

Not yet recruiting

• Conditions: Laxity; Skin; Scar; Wrinkle
• Interventions: Device: Karisma

• Registration Number: NCT06336044
• Lead Sponsor: Taumedika s.r.l.

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Study Start: 2025-06
• Primary Completion: 2025-11
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard patients	Karisma	Patients treated with the experimental Medical Device

Primary Outcome Measures

Name	Time	Method
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 with skin hydratation measurement

Secondary Outcome Measures

Name	Time	Method
Duration of the efficacy	16 weeks	measure the duration of the treatment