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To compare the efficacy and side effect profile of injectable and oral form of beta blocker drug propranolol in a type of vascular mass of the eye region

To Evaluate the Role of Intralesional Propranolol for treatment of periorbital and eyelid capillary haemangiomas as compared with Oral Propranolol

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009440
Enrollment
20
Registered
2017-08-22
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- periorbital and eyelid capillary haemangioma

Interventions

Intervention1: intralesional propranolol: Group B will receive intralesional propranolol in the form of a single injection with 26 gauge needle. The propranolol used will be provided by the pharmacy o
then 2mg/kg/day in three divided doses on day 3 & 4 and then 3mg/kg/day in three divided doses to be continued

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Newly diagnosed cases of periorbital and eyelid capillary haemangiomas 2 Only those patients or whose guardians sign a written informed consent 3 No complications like ulceration/ necrosis 4 No previous intervention 5 No history of any systemic illness including asthma/ heart disease/ diabetes mellitus 6 No history of developmental delay

Exclusion criteria

Exclusion criteria: 1 Patients not willing for treatment or follow up 2 Previously treated patients 3 Presence of systemic illnesses including recurrent breathing problem/ asthma; cardiac problems including AV block, CHF, sinus bradycardia; history of seizures; history of diabetes mellitus - Abnormalities found in blood investigations - Failure to get Cardiology Clearance for the intervention - Additional ocular pathologies

Design outcomes

Primary

MeasureTime frame
resolution of lesionTimepoint: 6 months

Secondary

MeasureTime frame
No change in size with continuous propranolol for 3 months Timepoint: 3 months;Obvious enlargement of lesion despite continuous treatment for 2 months Timepoint: 2months;Partial regression followed by no response for 3 months Timepoint: 3 months

Countries

India

Contacts

Public Contactaditi mehta

Dr Rajendra Prasad Centre for Ophthalmic Sciences AIIMS

msbajaj32@hotmail.com

Outcome results

None listed

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