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Intralesional Bleomycin Sclerotherapy for Low-Flow Vascular Malformations of the Head and Neck
Sponsor: University Of Anbar
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.
Official title: Evaluation of the Efficacy of Intralesional Bleomycin Injections for the Treatment of Low-Flow Vascular Malformations: A Multi-Center Study in Iraq
Key Details
Gender
All
Age Range
1 Year - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-08-25
Completion Date
2026-04-26
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
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.
Locations (3)
Al-Fallujah Teaching Hospital
Fallujah, Al-Anbar Governorate, Iraq
Al-Najaf Al-Ashraf Teaching Hospital
Najaf, Najaf, Iraq
Al-Sadr Teaching Hospital
Najaf, Najaf, Iraq