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THIODERM ELATE for Volume Augmentation in Lips

NCT06133153 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-11

No results posted yet for this study

Summary

A pivotal, randomized, subject- and evaluator-blinded, controlled, non-inferiority, multicenter, parallel group comparison study to evaluate effectiveness and safety of THIODERM ELATE for lip augmentation in order to correct lip volume deficit

Conditions

  • Lip; Anomaly

Interventions

DEVICE

THIODERM ELATE

Thiomer-crosslinked Hyaluronic Acid Dermal Filler with Lidocaine for Injection into Lips

DEVICE

Juvéderm Ultra 3

BDDE-crosslinked Hyaluronic Acid Dermal Filler with Lidocaine for Injection into Lips

Sponsors & Collaborators

  • Proinnovera GmbH

    collaborator INDUSTRY

  • Croma-Pharma GmbH

    lead INDUSTRY

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
2024-03-31
Primary Completion
2025-08-31
Completion
2026-04-30

Countries

  • Austria

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 NCT06133153 on ClinicalTrials.gov