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to evaluate Efficacy and Safety of oral Propranolol in enlarging Hemangioma in children less than one year.

Efficacy and Safety of Propranolol on the Proliferative Phase of Infantile Hemangioma - -

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/003975
Enrollment
30
Registered
2013-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: null- proliferative phase of infantile hemangioma

Interventions

Intervention1: drug: Propranolol for less than 7 kg weight: dose: 5 milligrams frequency:twice a day (12 hourly) route of administration: oral for more than 7 kg weight: dose: 5 milligrams frequen

Sponsors

GCS Medical College and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Infants under 12 months • Presenting a hemangioma with the following characteristics: o subcutaneous and / or cutaneous o Minimum diameter of 1.5cm on face, 5cm outside face and 1cm if it is ulcerated. o without functional impairment requiring treatment or oral corticosteroid • Consent of both parents (or the person having parental authority in families)

Exclusion criteria

Exclusion criteria: age: more than 12 months. • Indication of treatment with corticosteroids for an indication other than hemangioma • Indication of treatment with beta-blocker for another indication that the hemangioma • Infant presenting contra-indications for the administration of propranolol

Design outcomes

Primary

MeasureTime frame
efficacy will be evaluated using a VAS (visual analogue scale) on a series of photos at Day 0, Day 30, Day 60 and Day 90. It will also evaluated by size measurement by ultra-sonography(USG). safety will be evaluated at every visit by reporting all adverse eventsTimepoint: Day 0, Day 30, Day 60 and Day 90

Secondary

MeasureTime frame
regression rate can be calculated.Timepoint: Day 0, Day 30, Day 60 and Day 90

Countries

India

Contacts

Public ContactDr Jigna Padhiyar

GCS Medical College and research centre

patelnayan78.np@gmail.com9925011309

Outcome results

None listed

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