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

NCT07728825 | Completed Phase 4

• 1 other identifier: UOA-COD-OMFS-173
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Venous Malformation; Lymphatic Malformation; Vascular Malformations

Keywords

Bleomycin; Sclerotherapy; Head and Neck; Iraq

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in lesion volume

  Lesion volume derived from three orthogonal dimensions using the prolate ellipsoid formula (pi/6 x length x width x depth) on ultrasound or MRI, or by MRI volumetric segmentation for irregular lesions. Percentage reduction calculated relative to baseline volume.

  Baseline to 4 weeks after the final treatment session

Secondary Outcomes (1)

• Incidence and severity of adverse events

  From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks

Study Arms (1)

Intralesional bleomycin sclerotherapy

EXPERIMENTAL

All participants received intralesional bleomycin sclerotherapy.

Drug: Bleomycin (Bleocel 15)

Interventions

Bleomycin (Bleocel 15) DRUG

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.

Intralesional bleomycin sclerotherapy

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than one year
• Clinically and radiologically confirmed low-flow vascular malformation of the head and neck
• No prior bleomycin therapy
• Medically fit for outpatient intervention

You may not qualify if:

• High-flow vascular malformation
• Pregnancy or lactation
• Documented hypersensitivity to bleomycin
• Pre-existing pulmonary or hepatic disease
• Bleeding disorder or current anticoagulant use
• Renal impairment (serum creatinine \> 1.5 mg/dL or estimated glomerular filtration rate \< 60 mL/min/1.73 m²)
• Active infection at or near the treatment site

Sponsors & Collaborators

• University Of Anbar: lead

Study Sites (3)

Al-Fallujah Teaching Hospital

Fallujah, Al-Anbar Governorate, 54001, Iraq

Location

Al-Najaf Al-Ashraf Teaching Hospital

Najaf, Najaf, 54001, Iraq

Location

Al-Sadr Teaching Hospital

Najaf, Najaf, 54001, Iraq

Location

MeSH Terms

Conditions

Vascular Malformations; Lymphatic Abnormalities

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher, Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 27, 2026
• Study Start: August 25, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 26, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

IR (3)