CompletedNot Applicable

Efficacy of Intralesional Bleomycin Alone and in Combination With Dexamethasone in Infantile Haemangiomas

Pakistan114 participantsStarted 2021-03-22

Plain-language summary

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.

Who can participate

Age range1 Month – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Decrease in size of lesion

Timeframe: 1 year

Trial details

NCT IDNCT06080724

SponsorKing Edward Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-02

View on ClinicalTrials.gov More Comparison of Efficacy of Sclerotherapy in Infantile Hemangioma trials