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

NCT ID: NCT06336044

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Wrinkle Scar Laxity; Skin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

20 patients for face and 20 for lips will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Face treatment

Patients treated for face needs with Karisma micro injections

Group Type EXPERIMENTAL

Karisma

Intervention Type DEVICE

Intradermal injection

Lips treatment

Patients treated for face needs with Karisma microinjections

Group Type EXPERIMENTAL

Karisma

Intervention Type DEVICE

Intradermal injection

Interventions

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Karisma

Intradermal injection

Intervention Type DEVICE

Other Intervention Names

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Karisma filler

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nextrasearch S.r.l.s.

OTHER

Sponsor Role collaborator

Taumedika s.r.l.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adolfo Gasparetto, MD

Role: STUDY_DIRECTOR

Nextrasearch S.r.l.s.

Locations

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Ospedale Tor Vergata

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Campione, Professor

Role: CONTACT

+393382445642

Adolfo Gasparetto, MD

Role: CONTACT

+393356641965

Facility Contacts

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Elena Campione, Prof

Role: primary

+393382445642

Other Identifiers

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Taufiller/22

Identifier Type: -

Identifier Source: org_study_id

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