Injection Sclerotherapy With Bleomycin VS Doxycycline in Patients With Lymphatic Malformations

NCT07320001 | Not Yet Recruiting Phase 2

• 1 other identifier: BH-RCT-01
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lymphatic Abnormality

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months.

Secondary Outcomes (1)

• Number of participants with treatment-related complications within 6 months

  6 months.

Study Arms (2)

Bleomycin sclerotherapy

ACTIVE COMPARATOR

Drug: Bleomycin

Doxycycline sclerotherapy

EXPERIMENTAL

Drug: doxycycline (tetracycline)

Interventions

Bleomycin DRUG

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.

Bleomycin sclerotherapy

doxycycline (tetracycline) DRUG

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.

Doxycycline sclerotherapy

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 0-12 years Radiological diagnosis of macrocytic/mixed lymphatic malformations. No prior sclerotherapy/surgical treatment. Informed consent from guardians

You may not qualify if:

• microcytic lymphatic malformations Allergies to bleomycin/Doxycycline. Significant co morbidities Active infection at lesion site.

Sponsors & Collaborators

• Basharat Hussain: lead

MeSH Terms

Conditions

Lymphatic Abnormalities

Interventions

Bleomycin; Doxycycline; Tetracycline

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Basharat Hussain

CONTACT

03115130677; basharatbasharathussain@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 6, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12