WrinkleNCT06336044
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
A study testing Karisma in people with Wrinkle and Scar, run by Taumedika s.r.l. at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wrinkle, Scar, Laxity; Skin
- What is being tested?
- Karisma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2026to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all sexes
- caucasic
- 18 to 70 years
- non smoker
Who cannot join
- Pregnancy
- milking
- smoker
- alcohol or drugs abuse
- change of BMI during the study
- previous facial surgery, implants, permanent treatments
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- sensitivity to the product
- dermatological difficult frame
- health weakness
- treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Tor Vergata
Roma, 00133
Elena Campione, Prof, +393382445642, elena.campione@uniroma2.it
Elena Campione, Prof
About this study
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'"
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
Read the 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.
- Conditions
- Wrinkle, Scar, Laxity; Skin
- Being tested
- Karisma
- Keywords
- hyaluronic acid, Collagen, Filler, Wrinkles
- Medical subject headings
- Cicatrix, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarismaDevice
Also called Karisma filler
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Face treatment | Experimental | Patients treated for face needs with Karisma micro injections Receives: Device: Karisma |
| Lips treatment | Experimental | Patients treated for face needs with Karisma microinjections Receives: Device: Karisma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: no adverse events
test the safety of the device evaluating any potential adverse event
Measured: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale
Measured: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)
Measured: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface evaluating the face volume
Measured: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface with skin hydratation measurement
Measured: 16 weeks
Secondary outcomes (1)
Duration of the efficacy
measure the duration of the treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 20 patients for face and 20 for lips will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taumedika s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Responsible party
- Sponsor
- Investigators
- Adolfo Gasparetto, MD, Study director, Nextrasearch S.r.l.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336044
- Sponsor's protocol ID
- Taufiller/22
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not foreseen