Clinical trial · Interventional
Nadolol Versus Propranolol in Children With Infantile Hemangiomas
Nadolol Versus Propranolol in Children With Infantile Hemangiomas: a Randomized, Controlled, Double-blinded Trial
NCT02505971CI-TRIAL-00047974completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled, double-blinded study.
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 |
|---|---|---|---|
| Nadolol | Drug | — | UNRESOLVED |
| Propranolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Nadolol group
- description
- 40 study participants will take Nadolol (oral liquid suspension)
- interventionNames
- Drug: Nadolol
- type
- ACTIVE_COMPARATOR
- label
- Propranolol group
- description
- 40 study paticipants will take Propranolol (oral liquid suspension)
- interventionNames
- Drug: Propranolol
Primary outcomes (1)
- measure
- The change in the bulk (size/extent) and color of the infantile hemangioma (IH)at Week 24 compared to baseline using Visual Analog Scale (VAS).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: * 1-6 months corrected age * Written parental informed consent * At least one of the following: * Size: hemangioma \>1.5 cm on the face or \>3 cm on other body parts * Causing or with potential for functional impairment (e.g. amblyogenic IH, ulcerated hemangioma) * Causing or with potential for cosmetic disfigurement (e.g. nasal tip, glabella location) Exclusion Criteria: * Contraindications to beta-blockers * Hypotension * Bradycardia * Hypoglycemia * Cardiac disease associated with decreased ejection fraction and/or \> second degree heart block * Bronchospasm (including bronchial asthma) * Allergic rhinitis * Corrected gestational age less than 1 month at screening * Patients with PHACES cerebral arteriopathy at risk of stroke * Patients and/or breastfeeding mothers receiving treatment with anti-arrhythmic agents, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators, hypoglycemic agents, neuroleptics, antiacids, benzodiazepines, thyroxine, warfarin * Patients treated with an oral beta-blocker or other agent (e.g. systemic steroids, vincristine) within 2 weeks from randomization * Patients treated with topical timolol within 1 week from randomization * Vascular tumors other than infantile hemangioma (e.g. pyogenic granuloma, hemangioendothelioma)
References
Publications (1)
- DERIVEDPope E, Lara-Corrales I, Sibbald C, Liy-Wong C, Kanigsberg N, Drolet B, Ma J. Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangioma: A Randomized Clinical Trial. JAMA Pediatr. 2022 Jan 1;176(1):34-41. doi: 10.1001/jamapediatrics.2021.4565. PMID 34747977