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NCT06336044 | NOT YET RECRUITING | Wrinkle


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

Taumedika s.r.l.

Brief 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

Condition or disease

Wrinkle

Scar

Laxity; Skin

Intervention/treatment

Karisma

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Voluming Filler Based on Hyaluronic Acid Recombinant Collagen
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-03
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT06336044


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