Hyaluronic acid plus recombinant collagen volumizing filler for facial wrinkles and sagging
"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'"
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Taumedika s.r.l. Industry-sponsored |
| Locations | 1 site (Roma) |
| Trial ID | NCT06336044 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma
- Ospedale Tor Vergata — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Campione, Professor
- Email: elena.campione@uniroma2.it
- Phone: +393382445642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.