This is a randomized clinical trial comparing the safety and effectiveness of injection sclerotherapy using bleomycin versus doxycycline in children under 12 years with lymphatic malformations. The study will assess reduction in lesion size, clinical improvement, and treatment-related complications over six months.
None
microcytic lymphatic malformations Allergies to bleomycin/Doxycycline. Significant co morbidities Active infection at lesion site.
Parallel
Bleomycin
DrugInjection sclerotherapy using bleomycin administered according to standard hospital protocol. The number of sessions and dosage are determined based on lesion size and patient response. Safety and adverse events are monitored by the principal investigator and treating physicians.
doxycycline (tetracycline)
DrugInjection sclerotherapy using doxycycline administered according to hospital protocol. The number of sessions and dosage are determined based on lesion size and patient response. Safety and adverse events are monitored by the principal investigator and treating physicians.
Change in lymphatic malformation volume from baseline at 6 months
Change in lymphatic malformation size measured as percentage reduction in lesion volume from baseline, assessed using ultrasonography (or MRI, if you are using MRI) at baseline and at 6 months after sclerotherapy.
Number of participants with treatment-related complications within 6 months
Number of participants who develop treatment-related complications, including pain, fever, infection, skin necrosis, swelling, or ulceration, assessed clinically and graded using CTCAE v5.0 (or v4.0) within 6 months after sclerotherapy.
Click on the lead sponsor to view all of their trials.
Basharat Hussain
Lead sponsor
Holy Family Hospital, Pakistan
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
