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

January 22, 2026 updated by: Taumedika s.r.l.

"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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Roma, Italy, 00133
        • Recruiting
        • Ospedale Tor Vergata
        • Contact:
        • Principal Investigator:
          • Elena Campione, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Face treatment
Patients treated for face needs with Karisma micro injections
Device: Karisma
Intradermal injection
Other Names:
  • Karisma filler
Experimental: Lips treatment
Patients treated for face needs with Karisma microinjections
Device: Karisma
Intradermal injection
Other Names:
  • Karisma filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: no adverse events
Time Frame: 16 weeks
test the safety of the device evaluating any potential adverse event
16 weeks
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
16 weeks
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)
16 weeks
Efficacy: change of wrinkles and scars
Time Frame: 16 weeks
test the efficacy of the device measuring the skin surface evaluating the face volume
16 weeks
Efficacy: change of wrinkles and scars
Time Frame: 16 weeks
test the efficacy of the device measuring the skin surface with skin hydratation measurement
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the efficacy
Time Frame: 16 weeks
measure the duration of the treatment
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taumedika s.r.l.

Collaborators

Nextrasearch S.r.l.s.

Investigators

  • Study Director: Adolfo Gasparetto, MD, Nextrasearch S.r.l.s.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Taufiller/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not foreseen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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