Clinical trial · Interventional
Efficacy of Intralesional Bleomycin Alone and in Combination With Dexamethasone in Infantile Haemangiomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: This study is intended to compare the outcome of intralesional bleomycin with dexamethasone versus the bleomycin alone in infantile haemangioma. Materials and Methods: This RCT was performed after the ethical approval at the pediatric surgery department of KEMU/Mayo hospital Lahore. 114 patients were enrolled in two groups A and B. Both groups contained 57 patients each. Group A was administered intralesional bleomycin with dexamethasone and group B was given intralesional bleomycin alone with a space of 4 weeks. Selection of patients was made according to inclusions and exclusion criteria.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Comparison of Efficacy of Sclerotherapy in Infantile Hemangioma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparison of intralesional injection of bleomycin alone and combined with injection dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group A with intralesional injection of bleomycin with dexamethasone
- description
- Patients in the group A(n=57) were given intralesional bleomycin combined with dexamethasone and The intralesional dose of bleomycin was 1 mg/kg/dose but for haemangiomas on neck and face it was used as 0.5 mg/kg/dose and similarly intralesional dexamethasone was given as 0.8-1.6 mg/kg/dose. The Length, Width, Height and volume of haemangioma was measured in centimeters using a vernier calliper. The decrease in size was graded from 1-5 where 1=\<50% decrease, 2=50-75%, 3=75-90%, 4=\>90% but \<100% and 5= 100% resolution. The data collection sheet included patent's age, sex, length, width, height, volume, site of haemangioma, dose of bleomycin, dexamethasone, clinical response being efficacious or non-efficacious as per operational definition and time taken to resolve for each patient.
- interventionNames
- Drug: Comparison of intralesional injection of bleomycin alone and combined with injection dexamethasone
- type
- OTHER
- label
- Group B WITH INTRALESIONAL INJECTION OF BLEOMYCIN
- description
- Patients in the group B(n=57) intralesional bleomycin alone after taking aseptic and antiseptic measuresThe intralesional dose of bleomycin was 1 mg/kg/dose but for haemangiomas on neck and face it was used as 0.5 mg/kg/dose.The Length, Width, Height and volume of haemangioma was measured in centimeters using a vernier calliper. The decrease in size was graded from 1-5 where 1=\<50% decrease, 2=50-75%, 3=75-90%, 4=\>90% but \<100% and 5= 100% resolution. The data collection sheet included patent's age, sex, length, width, height, volume, site of haemangioma, dose of bleomycin, dexamethasone, clinical response being efficacious or non-efficacious as per operational definition and time taken to resolve for each patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with haemangioma with size equal or more than 1 c * Less than 12 years and above 1 month of age. Exclusion Criteria: * Patients with previous surgical procedure for haemangiomas * Patients with chronic respiratory conditions confirmed by history, symptoms and physical examination. * The diagnosed case of pulmonary fibrosis. * Patients sensitive to bleomycin proved upon giving a test dose
References
Publications (0)
Data not yet available