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

Launched by TAUMEDIKA S.R.L. · Mar 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of filler made from hyaluronic acid and collagen, which is designed to improve the appearance of wrinkles, scars, and loose skin. The goal is to see if this filler is both safe and effective for patients. The study will involve 40 participants who will visit the clinic three times: first to assess their health and apply the filler, then again after four weeks to check the results, and finally at 16 weeks for a last evaluation.

To participate, individuals must be between 18 and 70 years old, of Caucasian descent, and should not smoke. Unfortunately, people who are pregnant, breastfeeding, or have certain health conditions or past facial treatments may not be eligible. Throughout the trial, researchers will closely monitor participants for any side effects or reactions to ensure their safety. This trial is not yet recruiting participants, but it aims to gather important information about how this new filler works for improving skin appearance.

Gender

ALL

Eligibility 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