to evaluate Efficacy and Safety of oral Propranolol in enlarging Hemangioma in children less than one year.
Phase 2
Completed
- Conditions
- Health Condition 1: null- proliferative phase of infantile hemangioma
- Registration Number
- CTRI/2013/09/003975
- Lead Sponsor
- GCS Medical College and research centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Infants under 12 months
•Presenting a hemangioma with the following characteristics:
osubcutaneous and / or cutaneous
oMinimum diameter of 1.5cm on face, 5cm outside face and 1cm if it is ulcerated.
owithout functional impairment requiring treatment or oral corticosteroid
•Consent of both parents (or the person having parental authority in families)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method regression rate can be calculated.Timepoint: Day 0, Day 30, Day 60 and Day 90