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COMPLETED
NCT07728825
PHASE4

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

Sponsor: University Of Anbar

View on ClinicalTrials.gov

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

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.

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