Propranolol in Capillary Hemangiomas

NCT00744185 | Terminated Phase 2 DMC

• 2 other identifiers: CHUBX 2007/272008-000202-36
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hemangioma, Capillary

Keywords

infantile capillary hemangiomas; propranolol; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.

  30 days treatment

Secondary Outcomes (2)

• Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment.

  30 days-treatment

• Observance

  30 days-treatment

Study Arms (2)

2

PLACEBO COMPARATOR

30-days placebo treatment

Drug: placebo treatment

1

EXPERIMENTAL

30-days propranolol treatment

Drug: propranolol treatment

Interventions

propranolol treatment DRUG

30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days

1

placebo treatment DRUG

30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days

2

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Dermatologie Pédiatrique

Bordeaux, 33 076, France

Location

Related Publications (8)

• Leaute-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 BACKGROUND

• Tortoriello 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 BACKGROUND

• Villain 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 BACKGROUND

• Kilian 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 BACKGROUND

• Fritz 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 BACKGROUND

• Leaute-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 RESULT

• Prey 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.

  PMID: 26813215 RESULT

• Boccara O, Maruani A, Leaute-Labreze C. [Benign aggressive vascular anomalies in children]. Bull Cancer. 2018 Jun;105(6):610-625. doi: 10.1016/j.bulcan.2018.01.016. Epub 2018 Mar 20. French.

  PMID: 29571951 RESULT

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Nicholas Moore, Professor

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 1, 2026

Record last verified: 2012-07

Locations

FR (1)