A Clinical trial to study the effect of two drugs given orally,Steroids ( prednisolone) and propranolol in children less than 1 year of age with infantile hemangiomas ( Benign tumour of blood vessels)

Randomized trial of systemic steroids (prednisolone) and propranolol in the treatment of Infantile Hemangiomas

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003267

Enrollment

Registered

2012-12-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Infantile Hemangiomas

Interventions

Intervention1: Prednisolone suspension, Propranolol tablet: Prednisolone(15mg/5ml) 3 mg/kg/day OD for 6 months, Propranolol(10mg) 1mg/kg/day in 3 divided doses for 1 week followed by 2mg/kg/day in 3 d

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age up to 1 year 2. Active Infantile hemangioma having functional or cosmetic concern.(Nasal tip, eye lids, ears, face, genitalia) 3. Infantile hemangiomas with ulcerations/hemorrhage/necrosis 4. Infantile hemangiomas with life threatening locations (mouth, tongue, and upper airways 5. Infantile hemangiomas with > 5 lesions

Exclusion criteria

Exclusion criteria: 1. Age more than 1 year 2. Congenital Hemangiomas (Fully developed hemangiomas at birth) [Rapidly involuting congenital hemangiomas (RICH) and Non involuting congenital hemangiomas (NICH) 3. Children with bleeding diathesis 4. Systemic involvement.

Design outcomes

Primary

Measure	Time frame
1 The number of children who had complete flattening of hemangiomas 2 The rate at which flattening occurs in both the groups 3 Duration of remission. Timepoint: 1,3, and 6 months	—

Secondary

Measure	Time frame
1 Adverse effectsTimepoint: 1,3, and 6 months	—

Countries

India

Contacts

Public ContactDr V Sreenivas

All India Institute of Medical Sciences

aiimsgsr@gmail.com911126594369

Outcome results

None listed

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