Skip to content

Study to compare effects of timolol eye drops versus oral propranolol in patients of infantile hemangioma

The comparative study of the efficacy of topical 0.5% timolol ophthalmic solution and oral propranolol in the treatment of infantile hemangioma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023700
Enrollment
34
Registered
2020-03-02
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: D180- Hemangioma

Interventions

Intervention1: Oral Propranolol: Dosage of 2mg/kg/day, but starting dose is 0.33mg/kg/dose given 8th hourly for the first one week. After the one week follow up visit the dose is doubled to 0.67mg/kg/

Sponsors

Mahatma Gandhi Mission Ethics Committee for Research on Human Subjects
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient parents willing to undergo treatment and ready to bring the patient for followup. Focal and localized hemangioma.

Exclusion criteria

Exclusion criteria: Patients who have contraindications for beta blockers. Extra cutaneous and multifocal hemangioma.

Design outcomes

Primary

MeasureTime frame
Decrease in size. Change in colour change in consistency Change in surface Change in depth by ultrasoundTimepoint: Once a week for first two weeks, once every two weeks for next two months and then once a month thereafter for 6 months

Secondary

MeasureTime frame
Side effects of propranolol are hypotension, bradycardia, hyperkalemia, bronchospasm, hypoglycemia, restless sleep, constipation, diarrhea, hypothermia, nausea,vomiting, gastro esophageal reflux and cold extremities.Timepoint: Once a week for first two weeks, once every two weeks for next two months and then once a month thereafter for 6months.

Countries

India

Contacts

Public ContactDr A D Gulanikar

MGM Medical College and Hospital

agulanikar@hotmail.com9822377963

Outcome results

None listed

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