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An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel

NCT05853224 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-05-10

No results posted yet for this study

Summary

The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of Soft Tissue Deficits.

Conditions

  • Dermal Filler
  • Volume Deficiency of the Midface

Interventions

DEVICE

Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine

The injection should be performed at variable depth of the skin (dermal or subdermal), depending on the area to be treated and on the product variants, in accordance to the IFU of the IPs

Sponsors & Collaborators

  • 1Med

    collaborator OTHER

  • Biopolimeri Srl

    lead INDUSTRY

Principal Investigators

  • Paolo Persichetti, Prof. · Fondazione Policlinico Universitario Campus Bio-Medico Roma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-02
Primary Completion
2023-12-02
Completion
2023-12-02

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 NCT05853224 on ClinicalTrials.gov