Clinical trial · Interventional
Propranolol in Capillary Hemangiomas
Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study halted prematurely due to some difficulties in recruitment of patients
Summary
Brief summary (as posted)
The investigators observed that Propranolol, a beta-blocker commonly used in children was efficient to control the growth of alarming hemangiomas of the face. The primary objective of this study is to determine the efficiency of 1 month-early treatment of propranolol in infants aged less than 4 months affected by an hemangioma without any consequences on vital or functional structure and not justifying corticosteroids. The secondary objectives are: * the kinetic of the hemangioma evolution in infants treated by propranolol * Observance * Safety
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 |
|---|---|---|---|
| Hemangioma, Capillary | Capillary Hemangioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo treatment | Drug | — | UNRESOLVED |
| propranolol treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- 30-days placebo treatment
- interventionNames
- Drug: placebo treatment
- type
- EXPERIMENTAL
- label
- 1
- description
- 30-days propranolol treatment
- interventionNames
- Drug: propranolol treatment
Primary outcomes (1)
- measure
- Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
- timeFrame
- 30 days treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 4 Months
Show eligibility criteria text
Inclusion Criteria: * Infant aged less than 4 months * Infant with one or more hemangiomas sized more than 1 cm diameter * Infant not threatening for vital or functional structure and for which no treatment would be proposed * Informed consent * Patient with social insurance. Exclusion Criteria: * Alarming hemangioma (s) (complicated forms or localization at risk) * Cardiac pathology (cardiac malformation, heart failure, cardiac arrhythmias, pulmonary hypertension) * Asthma * Bronchopulmonary dysplasia * Bronchiolitis * Raynaud syndrome * Phéochromocytoma * Development of serious form of hemangioma (bleeding, necrosis, ulceration, infection, respiratory distress) requiring standard treatment
References
Publications (8)
- BACKGROUNDLeaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available. PMID 18550886
- BACKGROUNDTortoriello TA, Snyder CS, Smith EO, Fenrich AL Jr, Friedman RA, Kertesz NJ. Frequency of recurrence among infants with supraventricular tachycardia and comparison of recurrence rates among those with and without preexcitation and among those with and without response to digoxin and/or propranolol therapy. Am J Cardiol. 2003 Nov 1;92(9):1045-9. doi: 10.1016/j.amjcard.2003.06.002. PMID 14583354
- BACKGROUNDVillain E, Denjoy I, Lupoglazoff JM, Guicheney P, Hainque B, Lucet V, Bonnet D. Low incidence of cardiac events with beta-blocking therapy in children with long QT syndrome. Eur Heart J. 2004 Aug;25(16):1405-11. doi: 10.1016/j.ehj.2004.06.016. PMID 15321698
- BACKGROUNDKilian K. Hypertension in neonates causes and treatments. J Perinat Neonatal Nurs. 2003 Jan-Mar;17(1):65-74; quiz 75-6. doi: 10.1097/00005237-200301000-00006. PMID 12661740
- BACKGROUNDFritz KI, Bhat AM. Effect of beta-blockade on symptomatic dexamethasone-induced hypertrophic obstructive cardiomyopathy in premature infants: three case reports and literature review. J Perinatol. 1998 Jan-Feb;18(1):38-44. PMID 9527943
- RESULTLeaute-Labreze C, Dumas de la Roque E, Nacka F, Abouelfath A, Grenier N, Rebola M, Ezzedine K, Moore N. Double-blind randomized pilot trial evaluating the efficacy of oral propranolol on infantile haemangiomas in infants < 4 months of age. Br J Dermatol. 2013 Jul;169(1):181-3. doi: 10.1111/bjd.12217. No abstract available. PMID 23301692
- RESULTPrey S, Voisard JJ, Delarue A, Lebbe G, Taieb A, Leaute-Labreze C, Ezzedine K. Safety of Propranolol Therapy for Severe Infantile Hemangioma. JAMA. 2016 Jan 26;315(4):413-5. doi: 10.1001/jama.2015.13969. No abstract available.