RecruitingNot Applicable

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

Italy40 participantsStarted 2026-02

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety: no adverse events

Timeframe: 16 weeks

Efficacy: change of wrinkles and scars

Timeframe: 16 weeks

Efficacy: change of wrinkles and scars

Timeframe: 16 weeks

Efficacy: change of wrinkles and scars

Timeframe: 16 weeks

Efficacy: change of wrinkles and scars

Timeframe: 16 weeks

Trial details

NCT IDNCT06336044

SponsorTaumedika s.r.l.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Elena Campione, Professor

+393382445642 elena.campione@uniroma2.it

View on ClinicalTrials.gov More Wrinkle trials