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

Taumedika

Status: Enrolling

Conditions: Laxity; Skin; Scar; Wrinkle

Treatments: Device: Karisma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06336044

Taufiller/22

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Face treatment

Experimental group

Description:

Patients treated for face needs with Karisma micro injections

Treatment:

Device: Karisma

Lips treatment

Experimental group

Description:

Patients treated for face needs with Karisma microinjections

Treatment:

Device: Karisma