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

NCT06336044 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-26

No results posted yet for this 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

Conditions

  • Wrinkle
  • Scar
  • Laxity; Skin

Interventions

DEVICE

Karisma

Intradermal injection

Sponsors & Collaborators

  • Nextrasearch S.r.l.s.

    collaborator OTHER

  • Taumedika s.r.l.

    lead INDUSTRY

Principal Investigators

  • Adolfo Gasparetto, MD · Nextrasearch S.r.l.s.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06336044 on ClinicalTrials.gov