HEMANGIOL study

Has your baby developed infantile hemangioma, also known as strawberry birthmark?

If your child has developed infantile hemangioma (also known as strawberry birthmark), a new research study may be of interest to you.

THIS STUDY MAY BE APPROPRIATE FOR YOUR CHILD IF HE/SHE:
· Is between 35-150 days old
· Has at least one hemangioma 1.5 cm in diameter
· Has not received previous treatment for hemangioma

Infantile hemangiomas (IH) are red blemishes or bumps made up of small blood vessels. They affect around 3 to 10% of children born, and may appear on the head, face and neck in approximately 50% of cases. They are often not present at birth and usually become more obvious in the first weeks thereafter. Although many IHs shrink and disappear without medical intervention by the age of 10, some do not and may cause residual lesions and/or complications including vision and airway obstruction. Current IH treatments include surgery, laser treatment, cryotherapy, corticosteroids and vincristine. The HEMANGIOL study looks to explore a new possibility by determining whether a treatment that is already licensed and used for various conditions in adults can reduce hemangioma growth in infants aged 35 – 150 days. The HEMANGIOL study will compare a placebo to propranolol in approximately 450 children with IH worldwide.

The HEMANGIOL study is enrolling at doctor’s offices in California, Georgia, Illinois, Maryland, Massachusetts, Missouri, New York, Oregon, Pennsylvania, Texas and Washington. To learn more about the HEMANGIOL study or to pre-qualify your baby, visit www.birthmarkstudy.com or call 800-658-7871.

Also:

Three centres in Australia are conducting a research study looking infants with proliferating infantile hemangiomas (IHO) that require medication. This study will evaluate the use of an investigational drug, V00400 SB (also known propranolol) in the treatment of hemangiomas.

THIS STUDY MAY BE APPROPRIATE FOR YOUR CHILD IF HE/SHE:
· Is between 35-150 days old
· Has at least one hemangioma 1.5 cm in diameter
· Has not received previous treatment for hemangioma.

Infantile hemangiomas (IH) are red blemishes or bumps made up of small blood vessels. They affect around 3 to 10% of children born, and may appear on the head, face and neck in approximately 50% of cases. They are often not present at birth and usually become more obvious in the first weeks thereafter. Although many IHs shrink and disappear without medical intervention by the age of 10, some do not and may cause residual lesions and/ or complications including vision and airway obstruction. Current IH treatments include surgery, laser treatment, cryotherapy, corticosteroids and vincristine. The HEMANGIOL study looks to explore a new possibility by determining whether a treatment that is already licensed and used for various conditions in adults can reduce hemangioma growth in infants aged 35 – 150 days. The HEMANGIOL study will compare a placebo to propranolol in approximately 450 children with IH worldwide.

If you wish your child being seen to evaluate potential participation in this clinical trial, please contact:

– Sydney Children’s Hospital (Randwick – Sydney) – Dr Orli Wargon
Name of the person to contact : Susan Smith
Phone number: 9382 0512 or 0410 341 114
Email: susan.j.smith@sesiahs.health.nsw.gov.au

– Royal Children’s Hospital (Melbourne) – Dr Roderic Phillips
Name of the person to contact : Rod Phillips
Phone number: 03 93455522
Email: rod.phillips@rch.org.au

– Box Hill Hospital (Box Hill – Melbourne) – Dr John Su
Name of the person to contact : Althea Barr
Phone number: 9094 9544 or 0448 040 185
Email: althea.barr@monash.edu

Two centres in New Zealand are conducting a research study treating infants with proliferating infantile haemangiomas (IH), previously called strawberry birthmarks, with a medicine known as propranolol (V00400 SB). This medication has been used for many years in infants with heart problems.

THIS STUDY MAY BE APPROPRIATE FOR YOUR CHILD IF HE/SHE :
• Is between 35-150 days of age
• Has at least one haemangioma, 1.5 cm in size
• Has not received any treatment for the haemangioma.

Infantile haemangiomas (IH) are red blemishes or bumps made up of small blood vessels. Up to 1 in 10 newborns may develop one. They can appear anywhere on the body but about half do so on the head, face or neck. They are often not present at birth but become more obvious in the first weeks of life. Whilst many haemangiomas will shrink and disappear by the age of 10 years without treatment, some do not. Current haemangioma treatments include surgery, laser treatment, cryotherapy, oral steroids and vincristine. The HEMANGIOL study looks at using a well established heart medicine, propranolol (used to control heart rhythm and blood pressure in both children and adults) to treat infantile haemangiomas in infants 35 – 150 days of age. The HEMANGIOL study will compare a placebo (a dummy medicine) to propranolol, in approximately 450 children worldwide.

If you are interested in your child being seen to evaluate potential participation in this clinical trial, please contact:
Waikato Clinical Research (Hamilton) – Prof Marius Rademaker
Contact person:    Andrea Port or Eileen Bisley
Phone number:    07 843 0105 or 027 252 0990
Email:   research@wc.net.nz

Auckland Dermatology (Auckland) – Dr Nicholas Birchall
Contact person:   Susan Devonshire
Phone number:   0220 807112
Email:   nick.birchall@dermatology.co.nz