Hemangioma, CapillaryPhase 2/3HEMANGIOMANCT00744185
Propranolol in Capillary Hemangiomas
A Phase 2/3 study testing propranolol treatment in people with Hemangioma, Capillary, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Hemangioma, Capillary
- What is being tested?
- propranolol treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Apr 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
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
Read the detailed description
Infantile hemangiomas are frequent vascular tumors (4 à 10 % of the neonates) and correspond to 100 new cases per year in dermatology consultation of the CHU of Bordeaux. Hemangiomas have a characteristic clinical course marked by early proliferation during 3 to 12 months followed by slow and spontaneous involution from 3 to 7 years. Occasionally, as well as esthetical damages, hemangiomas may impair vital structures, ulcerate, bleed, or cause high-output cardiac failure or significant structural abnormalities. Standard treatments (corticotherapy, interferon, vincristine…) lead to a stagnation of hemangiomas in some cases, but with frequent side effects.
We observed that Propranolol, a beta-blocker usually used in neonates could lead to a decreased in volume of serious haemangiomas of the face (article published in New England Journal of Medicine).
In this study, we proposed to determine the efficiency of 1 month-early treatment of propranolol in neonates aged less than 4 months affected by non alarming hemangioma and not justifying corticotherapy. This is a double blind randomized placebo controlled study of propranolol.
Infants will be recruited from the dermatology consultation of CHU Bordeaux. After verification of eligibility criteria and informed consent of legal surrogates, infants will be randomized to receive either propranolol or either placebo. The infants will be observed during 1 month according to the following visits.
- Conditions
- Hemangioma, Capillary
- Being tested
- propranolol treatment, placebo treatment
- Keywords
- infantile capillary hemangiomas, propranolol, ultrasonography
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranolol treatmentDrug
30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
placebo treatmentDrug
30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | 30-days placebo treatment Receives: Drug: placebo treatment |
| 1 | Experimental | 30-days propranolol treatment Receives: Drug: propranolol treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
Measured: 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.
Measured: 30 days-treatment
Observance
Measured: 30 days-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Study halted prematurely due to some difficulties in recruitment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hemangioma, CapillaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Moore, Professor, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744185
- Sponsor's protocol ID
- CHUBX 2007/27
- Other IDs
- 2008-000202-36, 2008
- Acronym
- HEMANGIOMA
- Status last verified
- Jul 2012
- First submitted
- 28 Aug 2008
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18550886Tortoriello 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.
PubMed 14583354Villain 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.
PubMed 15321698Kilian 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.
PubMed 12661740Fritz 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.
PubMed 9527943Leaute-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.
PubMed 23301692Prey 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.
PubMed 26813215Boccara 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.
PubMed 29571951
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
- ClinicalTrials.gov ID
- NCT00744185
- Acronym / sponsor ID
- HEMANGIOMA / CHUBX 2007/27
- Conditions
- Hemangioma, Capillary
- Keywords
- infantile capillary hemangiomas, propranolol, ultrasonography
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely due to some difficulties in recruitment of patients
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Infantile hemangiomas are frequent vascular tumors (4 à 10 % of the neonates) and correspond to 100 new cases per year in dermatology consultation of the CHU of Bordeaux. Hemangiomas have a characteristic clinical course marked by early proliferation during 3 to 12 months followed by slow and spontaneous involution from 3 to 7 years. Occasionally, as well as esthetical damages, hemangiomas may impair vital structures, ulcerate, bleed, or cause high-output cardiac failure or significant structural abnormalities. Standard treatments (corticotherapy, interferon, vincristine…) lead to a stagnation of hemangiomas in some cases, but with frequent side effects.
We observed that Propranolol, a beta-blocker usually used in neonates could lead to a decreased in volume of serious haemangiomas of the face (article published in New England Journal of Medicine).
In this study, we proposed to determine the efficiency of 1 month-early treatment of propranolol in neonates aged less than 4 months affected by non alarming hemangioma and not justifying corticotherapy. This is a double blind randomized placebo controlled study of propranolol.
Infants will be recruited from the dermatology consultation of CHU Bordeaux. After verification of eligibility criteria and informed consent of legal surrogates, infants will be randomized to receive either propranolol or either placebo. The infants will be observed during 1 month according to the following visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placebo treatment30-days placebo treatment |
| 1 | Experimental | Drug: propranolol treatment30-days propranolol treatment |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Alarming hemangioma (s) (complicated forms or localization at risk)
- Cardiac pathology (cardiac malformation, heart failure, cardiac arrhythmias, pulmonary hypertension)
- Asthma
- Bronchopulmonary dysplasia
- Bronchiolitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propranolol treatment30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days | Drug | 1 |
| placebo treatment30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days | Drug | 2 |
Primary outcome
Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
Time frame: 30 days treatment
2 secondary outcomes
Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment.
Time frame: 30 days-treatment
Observance
Time frame: 30 days-treatment
Results and safety
The study was stopped early (reason given: Study halted prematurely due to some difficulties in recruitment of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 18550886Leaute-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.
- Background: PubMed 14583354Tortoriello 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.
- Background: PubMed 15321698Villain 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.
- Background: PubMed 12661740Kilian 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.
- Background: PubMed 9527943Fritz 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.
- Results publication: PubMed 23301692Leaute-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.
- Results publication: PubMed 26813215Prey 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.
- Results publication: PubMed 29571951Boccara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Moore, Professor study chair
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing propranolol treatment in people with Hemangioma, Capillary, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely due to some difficulties in recruitment of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment. (time frame: 30 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744185, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.