MedTrace Logo

Efficacy and Safety Analysis of Polylauric Alcohol More Stable Foam Versus Ordinary Foam in the Treatment of Head and Neck Venous Malformations

NCT07066527 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-07-15

No results posted yet for this study

Summary

The aim of this study is to explore the efficacy and safety of poly -LRB-cinnamyl alcohol) foam in the treatment of venous malformations of head and neck through a prospective randomized clinical trial, this trial may provide better treatment options and evidence for head and neck VMs.

Conditions

  • Venous Malformation

Interventions

COMBINATION_PRODUCT

The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam

According to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • shaohua liu, Doctoral · Shandong University Qilu Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-12-30
Completion
2026-06-30

Countries

  • China

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 NCT07066527 on ClinicalTrials.gov