Comparison of Two topical agents in children suffering with Hemangioma

Phase 2

• Conditions: Health Condition 1: D492- Neoplasm of unspecified behavior of bone, soft tissue, and skinHealth Condition 2: P968- Other specified conditions originating in the perinatal period

• Registration Number: CTRI/2023/11/059391
• Lead Sponsor: All India Institute of Medical sciences, Raebareli, U.P.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All children less than <36 months of age having clinical and color Doppler-proven infantile capillary hemangioma (ICH).

1. Superficial ICH on Doppler, including mucosal surfaces, and ulcerated ICH

2. Size of lesion > 1.5 Cm

3.No H/O prior tt for ICH

4. Patients at risk of adverse effects of systemic beta-blockers like Cardiac arrhythmias, first-degree heart block; recovered pts of cardiogenic or hypotensive shock, sinus bradycardia, Asthma, history of hypoglycemia, birth weight < 2500 g would be included.

Exclusion Criteria

1. Age at the time of enrolment is >36 months

Dermal invasive ICH

2. Life-threatening ICH

3. Persistent arrhythmias, wheezing, heart failure

4. Associated Visceral vascular (liver/ renal/brain) lesions

5. Patients Having Raynaud phenomena

6. Bradycardia below the age-specific range for normal

7. Low blood pressure according to age-specific ranges for normal

8. known case of Pheochromocytoma

9. Breast-feeding mothers who are on treatment with oral propranolol

10. Renal failure

11. liver failure

12. Hyperkalemia

13. Psoriasis in infant

14. Infant or mother taking other drugs having synergistic, antagonistic action with beta blockers viz calcium channel blocker (Diltiazem, Verapamil, bepridil), Quinidine, Amiodarone (antiarrhythmic), Digitalis, Lidocaine, Dihydropyridines, Antihypertensives (ACE Inhibitors, angiotensin II-receptors antagonists, diuretics, alpha-blocker, Corticosteroid, (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen, rifampicin or phenobarbital and Hypoglycaemic agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures would be followed in the Proportion of patients in each group. To compare combined VAS  scores in two groups (excellent & good responses will be taken as treatment success).Timepoint: VAS  scores in two groups at the  1st week, 2nd week, 3rd week, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week months. <br/ ><br>A follow-up of 12 months will be done till the stop of treatment to see the rebound growth of ICH.

Secondary Outcome Measures

Name	Time	Method
Adverse events/Side effects of topical therapy viz local burning, stinging, or irritant reactions. Timolol Safety would be assessed by measuring heart rate & systolic and diastolic blood pressure. <br/ ><br>Parental satisfaction on 10 points line scale at the 24th week and stoppage of treatment. <br/ ><br>Timepoint: At 1st week, 2nd week, 3rd week, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week.