Clinical trial · Interventional
Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Through this study, the investigators shall compare the effectiveness of atenolol with propranolol in the treatment of IH. In addition, the investigators shall try to elucidate the mechanism of action of beta blockers by assessing their action on triggers such as hypoxia. The study design will be a parallel group comparative study wherein patients of IH will be randomized into two groups. One group will receive propranolol and the other atenolol for a maximum period of 9 months. The patients will then be followed up regularly for regression of the IH based on Physician global assessment, hemangioma activity score(HAS), serial photography and lesional ultrasonography. Any side effects encountered during the treatment period will also be noted. Also serial measurements of hypoxia inducible factor 1 alpha(HIF-1α) will be made to ascertain the mechanism of action of the drugs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infantile Hemangioma | Infantile Hemangioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral atenolol | Drug | — | UNRESOLVED |
| oral propranolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A- Propranolol
- description
- Oral propranolol 1mg/kg/day as crushed tablets, in two divided doses, increased to 2mg/kg/day in two divided doses after 24 hours if tolerated well. Treatment will be stopped at complete clinical clearance of lesion (defined arbitrarily as \>90% reduction in the size of Infantile Hemangioma as assessed by Physician Global Assessment) or after 9 months of treatment (primary end point) whichever is earlier.
- interventionNames
- Drug: oral propranolol
- type
- EXPERIMENTAL
- label
- Group B- Atenolol
- description
- Oral atenolol 0.5mg/kg as a single dose, increased to 1mg/kg as a single dose after 24 hours if tolerated well. Treatment will be stopped at complete clinical clearance of lesion (defined arbitrarily as \>90% reduction in the size of Infantile Hemangioma as assessed by Physician Global Assessment) or after 9 months of treatment (primary end point) whichever is earlier.
- interventionNames
- Drug: oral atenolol
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 12 Months
Show eligibility criteria text
Inclusion Criteria: 1. Children diagnosed with problematic infantile hemangiomas 1. Potentially disfiguring infantile hemangiomas at any site. 2. Functionally threatening infantile hemangiomas near the eyes, nose, natural orifices, limbs, genitalia. 3. Ulcerated infantile hemangiomas. 4. Segmental infantile hemangiomas. 5. Uncomplicated progressive infantile hemangiomas with unpredictable future course. 2. Age group: less than 1 year of age. 3. Either sex 4. Multiple hemangiomas 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 hypoglycemia 5. Diabetes mellitus 6. Hypertension 7. Hypotension 8. Liver failure 9. Visceral hemangiomas 10. PHACES syndrome
References
Publications (0)
Data not yet available