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NCT06336044 Clinical Trial

Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Filler of Hyaluronic Acid Recombinant Collagen

Wrinkle Clinical Trial

Official title:
Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Voluming Filler Based on Hyaluronic Acid Recombinant Collagen

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06336044
Other study ID # Taufiller/22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date January 2025

Study information
Verified date March 2024
Source Taumedika s.r.l.
Contact Fabio Caviggioli, MD
Phone +393426179730
Email fabio.caviggioli@multimedica.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 20 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date January 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Karisma
Intradermal injection

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Taumedika s.r.l. Nextrasearch S.r.l.s.

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: no adverse events test the safety of the device evaluating any potential adverse event 16 weeks
Primary Efficacy: change of wrinkles and scars test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale 16 weeks
Primary Efficacy: change of wrinkles and scars test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS) 16 weeks
Primary Efficacy: change of wrinkles and scars test the efficacy of the device measuring the skin surface evaluating the face volume 16 weeks
Primary Efficacy: change of wrinkles and scars test the efficacy of the device measuring the skin surface with skin hydratation measurement 16 weeks
Secondary Duration of the efficacy measure the duration of the treatment 16 weeks
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