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

NCT07066527 | Recruiting

• 1 other identifier: KYLL-202207-006-2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Remission rate of venous malformations in head and neck

  Patients were satisfied and no further treatment was needed after clinical evaluation. This was the last treatment. The proportion of patients who responded to treatment was counted and compared between the two groups.

  3-4 weeks after treatment

Secondary Outcomes (3)

• Volume of venous malformation

  3-4 weeks after treatment

• Foam injection

  3-4 weeks after treatment

• Number of treatment

  According to the condition whether need to be treated again, is generally 3-4 weeks for a treatment.

Study Arms (2)

A common foam prepared from poly (cinnamyl alcohol)

NO INTERVENTION

1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs

More stable foams made from poly -LRB-cinnamyl alcohol)

ACTIVE COMPARATOR

0.05% 0.1 ml hyaluronic acid+1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs

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

Interventions

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

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.

More stable foams made from poly -LRB-cinnamyl alcohol)

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy)
• Clinical diagnosis and imaging () were consistent with head and neck venous malformations
• Participants volunteered to participate in the trial and signed an informed consent form.

You may not qualify if:

• People with serious systemic diseases, including heart disease, high blood pressure, diabetes, etc. , that are not under control. Heart Attack: 1. Recent frequent attacks of angina. 2. Recent history of myocardial infarction 3. Cardiac function grade iii-iv or with symptoms of sitting breathing, cyanosis, jugular venous distension, lower limb edema, etc. . 4. Heart disease complicated with hypertension 5. Type II or III Type II atrioventricular block, double bundle branch block, as syndrome, diabetes: blood sugar control in 8.88 mmol/L above, hypertension: after taking medicine blood pressure can not be controlled in the normal range namely systolic pressure below 140 mmhg, diastolic pressure below 90 mmhg)
• Patients who are unable to follow up on time;
• Persons who are mentally ill or have mental disorders;
• The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Shandong University Qilu Hospital

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• shaohua liu, Doctoral

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shaohua liu, Doctoral

CONTACT

+8618560083730; lshabccba@126.com

weiliang zhang, Bachelor

CONTACT

+8613678613566; 814831990@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: July 15, 2025
• Study Start: June 1, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)