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Efficacy and Safety of Different Polidocanol Injection Methods for Pediatric Pyogenic Granuloma: A Prospective Randomized Controlled Trial

Study on Polidocanol Sclerotherapy for Pyogenic Granuloma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115124
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyogenic Granuloma

Interventions

Group A (Intratumoral Injection Group):Needle Entry Point: The needle was inserted vertically at the skin surface projection, either directly above or lateral to the tumor. Puncture and Injection Pat
Group B (Compound Basal Injection Group) :Needle Entry Point: The needle was inserted through normal tissue approximately 2 mm from the margin of the lesion. Puncture and Injection Path: The needle

Sponsors

Jinan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.3 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age > 3 months, regardless of gender; 2.Met the typical clinical diagnostic criteria for PG, confirmed by color Doppler ultrasound; 3.Maximum lesion diameter ranging from 5 mm to 15 mm; 4.No prior treatment (such as surgical excision, laser therapy, cryotherapy, or sclerotherapy) for the target lesion; 5.No significant abnormalities in hepatic, renal, or coagulation functions; 6.Guardians fully understood the study protocols and signed the written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Known hypersensitivity or allergy to any component of the study drugs (polidocanol or lidocaine); 2.Concurrent severe cardiac, pulmonary, hepatic, renal, or hematological diseases; 3.Immunodeficiency or current use of immunosuppressive therapy; 4.Active infection at the lesion site; 5.Poor compliance of guardians, with an anticipated inability to complete the scheduled follow-up.

Design outcomes

Primary

MeasureTime frame
Cure rate at 4 weeks after the initial treatment;

Secondary

MeasureTime frame
Number of treatment sessions required for cure;Degree of scarring;Satisfaction score;

Countries

China

Contacts

Public ContactGuo Lei

Jinan Children's Hospital

etjrxgl@vip.163.com+86 136 9862 9521

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026