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Treatment of Superficial Infantile Haemangiomas with Timolol and Propranolol

Phase 4
Completed
Conditions
Health Condition 1: D180- Hemangioma
Registration Number
CTRI/2021/05/033307
Lead Sponsor
Varun Gupta
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the size of superficial Infantile haemangioma <br/ ><br> <br/ ><br>Timepoint: 0 week, 4wks, 8wks, 12wks, 16wks, 20wks, 24wks, 28wks, 32wks.
Secondary Outcome Measures
NameTimeMethod
To assess the adverse event seen with the study drugs. <br/ ><br>To assess the increase or decrease of size of haemangiomaTimepoint: 0 week, 4wks, 8wks, 12wks, 16wks, 20wks, 24wks, 28wks, 32wks.
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