MedTrace Logo

THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit

NCT06128109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-12

No results posted yet for this study

Summary

This mono-center clinical investigation is intended to evaluate the safety and effectiveness of THIODERM STRONG (test device) in the correction of moderate to severe midface volume deficit compared to Juvéderm® VOLUMA® Lidocaine (comparator device).

Conditions

  • Mid Face Volume Deficit

Interventions

DEVICE

Thioderm Strong

Test Device

DEVICE

Juvéderm VOLUMA Lidocaine

Comparator Device

Sponsors & Collaborators

  • Proinnovera GmbH

    collaborator INDUSTRY

  • Croma-Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Alice Krames-Juerss · CROMA Pharma GmbH (Sponsor)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-01-24
Primary Completion
2023-08-28
Completion
2024-01-09

Countries

  • Austria

Study Locations

More Related Trials

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 NCT06128109 on ClinicalTrials.gov