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Intralesional Bleomycin Sclerotherapy for Low-Flow Vascular Malformations of the Head and Neck

NCT07728825 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-27

No results posted yet for this study

Summary

This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.

Conditions

  • Vascular Malformations
  • Venous Malformation
  • Lymphatic Malformation

Interventions

DRUG

Bleomycin (Bleocel 15)

Intralesional injection of bleomycin diluted with normal saline to 3 mg/mL. Maximum 15 mg per session; up to four sessions at three- to four-week intervals; cumulative dose capped at 400 mg. Administered under local anaesthesia or conscious sedation, with ultrasound guidance for deep lesions.

Sponsors & Collaborators

  • University Of Anbar

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-04-16
Completion
2026-04-26

Countries

  • Iraq

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 NCT07728825 on ClinicalTrials.gov