NCT00555464 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

1
Drolet BA, Esterly NB, Frieden IJ. Hemangiomas in Children. NEJM 1999;341:173-180. 2.Haggstrom AN, Drolet BA, Baselga E, Chamlin S, Esterly NB, Garzon M, Horii K, Lucky A, Metry DW, Mancini AJ, Nopper A, Frieden IJ. Prospective study of infantile hemangiomas, part II:clinical characteristics predicting complications and treatment. Pediatrics 2006;118: 882-887. 3.Haggstrom A, Drolet BA, Baselga E, Chamlin SL, Esterly NB, Garzon MC,. Prospective study of infantile hemangiomas, Part I: Demographic, prenatal and perinatal characteristics. J Pediatr 2007; 150(3):291-4. 4.Frieden IJ, Reese V, Cohen D. PHACE syndrome. The association of posterior fossa brain malformations, hemangiomas, arterial anomalies, coarctation of the aorta and cardiac defects, and eye abnormalities. Archives of Dermatology 1996 132(3):307-11.

A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile

Clinical trial NCT00555464 - References