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Can a cancer drug shrink birthmarks? bleomycin injections put to the test

NCT ID NCT07728825

Disease control Sponsor: University Of Anbar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial investigates whether injecting bleomycin directly into low-flow vascular malformations (abnormal clusters of blood or lymph vessels) in the head and neck can shrink them. Twenty participants will receive up to four sessions of the drug under local anesthesia. The main goal is to measure how much the lesion volume decreases after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bleomycin injected directly into the malformation
What this could lead to
If effective, this could offer a non-surgical option to shrink low-flow vascular malformations, potentially improving appearance and function.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply widely. Bleomycin can cause side effects like skin changes or, rarely, lung problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

20 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Lymphatic Abnormalities lymphatic malformation vascular malformation venous hemangioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphatic malformation Vascular malformations Venous malformation

Contacts and locations

Locations

  • Al-Fallujah Teaching Hospital

    Fallujah, Al-Anbar Governorate, 54001, Iraq

  • Al-Najaf Al-Ashraf Teaching Hospital

    Najaf, Najaf, 54001, Iraq

  • Al-Sadr Teaching Hospital

    Najaf, Najaf, 54001, Iraq

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