NCT07320001

Injection Sclerotherapy With Bleomycin VS Doxycycline in Patients With Lymphatic Malformations

Injection Sclerotherapy With Bleomycin VS Doxycycline in Patients With Lymphatic Malformations:A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Basharat Hussain · Academic / Other
• Sex: All
• Age: 0 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This randomized clinical trial aims to compare the effectiveness and safety of injection sclerotherapy using bleomycin versus doxycycline in pediatric patients under 12 years of age diagnosed with lymphatic malformations. Eligible participants will be randomly assigned to receive either bleomycin or doxycycline injections at Holy family hospital Rawalpindi Pakistan. The study will monitor participants over a six-month follow-up period to assess primary outcomes, including reduction in lesion size and clinical improvement, as well as secondary outcomes such as treatment-related complications, number of treatment sessions required, and overall patient tolerance. Standard hospital protocols for injection sclerotherapy will be followed, and safety will be monitored by the principal investigator and treating physicians. Participants' caregivers will provide informed consent prior to enrollment. This study is designed to provide evidence on the comparative effectiveness of bleomycin versus doxycycline for pediatric lymphatic malformations

Conditions

• Lymphatic Abnormality

Interventions

Type	Name	Description
DRUG	Bleomycin	Injection 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.
DRUG	doxycycline (tetracycline)	Injection 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.

Timeline

• Start date: 2026-01-26
• Primary completion: 2026-07-26
• Completion: 2026-09-26
• First posted: 2026-01-06
• Last updated: 2026-01-06