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Treatment of Superficial Infantile Haemangiomas with Timolol and Propranolol

Comparison of topical timolol with oral Propranolol for the treatment of superficial infantile hemangiomas in children - TOProlinGioma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033307
Enrollment
40
Registered
2021-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: D180- Hemangioma

Interventions

Intervention1: timolol: 0.25 to 0.50% hydrogel, Local application, once daily for 24 weeks Control Intervention1: Propranolol: Tablet Propranolol with starting dose of 0.5mg/kg/day (Orally) in two di

Sponsors

Varun Gupta
Lead Sponsor
Guru GobinD Singh Medical College And Hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1. Children diagnosed with problematic infantile haemangioma, defined a) Potentially disfiguring infantile haemangioma at any site. b) Functionally threatening infantile haemangioma near the eyes, nose, natural orifices, limbs & genitalia. c) Segmental infantile haemangioma. d) Uncomplicated progressive infantile haemangioma. 2. Either sex. 3. Multiple haemangiomas.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Infants with heart disease, cardiac arrhythmias. 2. Broncho-obstructive disease. 3. Premature infants with corrected age less than 40 weeks. 4. Known hypoglycaemia. 5. Hypertension. 6. Hypotension. 7. Pediatric patients who have deranged LFT. 8. Visceral haemangiomas. 9. PHACES syndrome (Posterior fossa brain malformations, Hemangioma, Arterial lesions, Cardiac abnormalities, and Eye abnormalities). 10. Ulcerative haemangiomas. 11. Previously treated patients

Design outcomes

Primary

MeasureTime frame
To assess the size of superficial Infantile haemangioma Timepoint: 0 week, 4wks, 8wks, 12wks, 16wks, 20wks, 24wks, 28wks, 32wks.

Secondary

MeasureTime frame
To assess the adverse event seen with the study drugs. To assess the increase or decrease of size of haemangiomaTimepoint: 0 week, 4wks, 8wks, 12wks, 16wks, 20wks, 24wks, 28wks, 32wks.

Countries

India

Contacts

Public ContactAshish chhabbra

Guru Gobind Singh Medical College and hospital Faridkot

anurajkumar76@gmail.com9814286248

Outcome results

None listed

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