Hyaluronic acid plus recombinant collagen volumizing filler for facial wrinkles and sagging
Official title: "Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'"
Run by Taumedika s.r.l. · NCT06336044 · Data updated 2026-11-12
This trial will try a hyaluronic acid and recombinant collagen filler to reduce facial wrinkles, scars, and tissue laxity in non-smoking adults aged 18–70.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Taumedika s.r.l. Industry-sponsored |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | February 2027 |
| Study ends | April 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT06336044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are non-smoking Caucasian adults aged 18–70 with facial wrinkles, scars, or mild-to-moderate tissue laxity who have not had prior facial surgery or permanent implants.
✕Probably not a fit
People who are pregnant, breastfeeding, smokers, have prior facial implants or recent facial surgery, are sensitive to the product, or are taking anticoagulants or other contraindicated medications may not receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label pre-marketing trial enrolls 40 non-smoking Caucasian adults with facial laxity and wrinkles to receive microinjections of a hyaluronic acid plus recombinant collagen filler (Karisma) into the cheekbone area, lips, and marionette lines. Participants attend three visits: baseline for screening and treatment, a 4-week visit for non-invasive tissue measurements and early results, and a 16-week final visit for outcome and safety validation. Safety is monitored by recording and analyzing adverse events and clinical changes. The trial excludes pregnant or breastfeeding people, current smokers, those with prior facial surgeries or permanent implants, and people on medications that could affect results.
Why it matters
Potential benefit: If successful, the filler could provide improved facial volume and smoother skin with an acceptable short-term safety profile.
How similar studies have gone: Hyaluronic acid fillers have an established record of safety and effectiveness for facial volumizing, while combining HA with recombinant collagen is relatively novel and has limited published evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Ospedale Tor Vergata
Roma, Italy Recruiting
Study contacts
- Study coordinator: Elena Campione, Professor
- Email: elena.campione@uniroma2.it
- Phone: +393382445642
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.