ClinicalTrials.gg
RecruitingNCT06336044Updated Oct 2, 2026

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

An interventional study of Karisma in Wrinkle, Scar and Laxity; Skin, sponsored by Taumedika s.r.l.. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Taumedika s.r.l. · Not applicable, Interventional, and Treatment

Updated Oct 2, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

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.

02

Conditions studied

  • Wrinkle
  • Scar
  • Laxity; Skin

Browse trials for

Keywords

  • hyaluronic acid
  • Collagen
  • Filler
  • Wrinkles
03

In context

Cicatrix

611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 512 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

This is the only study on the registry with Taumedika s.r.l. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all sexes
  • caucasic
  • 18 to 70 years
  • non smoker

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • milking
  • smoker
  • alcohol or drugs abuse
  • change of during the study
  • previous facial surgery, implants, permanent treatments
  • sensitivity to the product
  • dermatological difficult frame
  • health weakness
  • treated with anticoagulants, antihistaminics, , antidepressants and other drugs impacting on the results
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Face treatment

    Patients treated for face needs with Karisma micro injections

    Device: Karisma

  • Experimental
    Lips treatment

    Patients treated for face needs with Karisma microinjections

    Device: Karisma

Interventions

  • DeviceKarisma

    Intradermal injection

    Also known as: Karisma filler

06

What researchers measure

Primary outcomes

  1. Safety: no adverse events

    test the safety of the device evaluating any potential adverse event

    Time frame: 16 weeks

  2. Efficacy: change of wrinkles and scars

    test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale

    Time frame: 16 weeks

  3. Efficacy: change of wrinkles and scars

    test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)

    Time frame: 16 weeks

  4. Efficacy: change of wrinkles and scars

    test the efficacy of the device measuring the skin surface evaluating the face volume

    Time frame: 16 weeks

  5. Efficacy: change of wrinkles and scars

    test the efficacy of the device measuring the skin surface with skin hydratation measurement

    Time frame: 16 weeks

Secondary outcomes

  1. Duration of the efficacy

    measure the duration of the treatment

    Time frame: 16 weeks

07

Study locations

1 of 1 sites recruiting
  • Ospedale Tor Vergata
    Roma, 00133, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Not foreseen

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.

Of 33 industry-sponsored interventional studies with no phase under Cicatrix, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 20. This study's planned 3 months is below that.

Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: start Feb 2026 → Nov 2026, primary completion Mar 2026 → Feb 2027 and completion Jun 2026 → Apr 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2024
First posted
Mar 28, 2024
StartEst.
Nov 2026was Feb 2026
Primary completionEst.
Feb 2027was Mar 2026
CompletionEst.
Apr 2027was Jun 2026
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Feb 2026→Nov 2026
Oct 2, 2026
Primary completion
Mar 2026→Feb 2027
Oct 2, 2026
Study completion
Jun 2026→Apr 2027
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Start date Feb 2026→Nov 2026
    Primary completion Mar 2026→Feb 2027
    Study completion Jun 2026→Apr 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06336044
Lead sponsor
Taumedika s.r.l.
Collaborators
Nextrasearch S.r.l.s.
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
Nov 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Elena Campione, Professor
Contact
elena.campione@uniroma2.it
+393382445642
Adolfo Gasparetto, MD
Contact
adolfogasparetto@nextrasearch.it
+393356641965
Adolfo Gasparetto, MD
study director · Nextrasearch S.r.l.s.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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