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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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'"
- ClinicalTrials.gov ID
- NCT06336044
- Acronym / sponsor ID
- Taufiller/22
- Conditions
- Wrinkle, Scar, Laxity; Skin
- Keywords
- hyaluronic acid, Collagen, Filler, Wrinkles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taumedika s.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 patients for face and 20 for lips will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks
| Arm | Type | Receives |
|---|---|---|
| Face treatment | Experimental | Device: KarismaPatients treated for face needs with Karisma micro injections |
| Lips treatment | Experimental | Device: KarismaPatients treated for face needs with Karisma microinjections |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- all sexes
- caucasic
- 18 to 70 years
- non smoker
Key exclusion criteria (10 listed)
- Pregnancy
- milking
- smoker
- alcohol or drugs abuse
- change of BMI during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KarismaAlso: Karisma fillerIntradermal injection | Device | Face treatment, Lips treatment |
Primary outcome
Safety: no adverse events
Time frame: 16 weeks
test the safety of the device evaluating any potential adverse event
Efficacy: change of wrinkles and scars
Time frame: 16 weeks
test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale
Efficacy: change of wrinkles and scars
Time frame: 16 weeks
test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)
Efficacy: change of wrinkles and scars
Time frame: 16 weeks
test the efficacy of the device measuring the skin surface evaluating the face volume
Efficacy: change of wrinkles and scars
Time frame: 16 weeks
test the efficacy of the device measuring the skin surface with skin hydratation measurement
1 secondary outcome
Duration of the efficacy
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Not foreseen
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adolfo Gasparetto, MD study director
Nextrasearch S.r.l.s.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karisma in people with Wrinkle and Scar, run by Taumedika s.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Campione, Professor (+393382445642, elena.campione@uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: no adverse events (time frame: 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.