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

NCT06336044 — Not applicable, Recruiting, 40 participants, Taumedika s.r.l.

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"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'"

Registry	NCT06336044
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Taumedika s.r.l. (Industry); collaborators: Nextrasearch S.r.l.s.
Conditions	Wrinkle, Scar, Laxity; Skin
Interventions	Karisma (Device)
Dates	start 2026-11-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-04-01 (estimated), first posted 2024-03-28, last updated 2026-10-02
Locations	1 site in Italy

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Face treatment	Experimental	Device: Karisma	Patients treated for face needs with Karisma micro injections
Lips treatment	Experimental	Device: Karisma	Patients treated for face needs with Karisma microinjections

Karisma (Device), also known as Karisma filler: Intradermal injection

+Outcome measures

Primary outcomes

Safety: no adverse events [16 weeks]: test the safety of the device evaluating any potential adverse event
Efficacy: change of wrinkles and scars [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 [16 weeks]: test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)
Efficacy: change of wrinkles and scars [16 weeks]: test the efficacy of the device measuring the skin surface evaluating the face volume
Efficacy: change of wrinkles and scars [16 weeks]: test the efficacy of the device measuring the skin surface with skin hydratation measurement

Secondary outcomes

Duration of the efficacy [16 weeks]: measure the duration of the treatment

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Ospedale Tor Vergata	Roma	Italy	Recruiting

+Investigators

Adolfo Gasparetto, MD, Study director, Nextrasearch S.r.l.s.