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Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

2014-08-27 03:16:22 | BioPortfolio

Summary

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

Description

Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Infantile Hemangioma

Intervention

Propranolol, Placebo

Location

University of California
Irvine
California
United States
92697-1385

Status

Recruiting

Source

Pierre Fabre Dermatology

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:22-0400

Clinical Trials [201 Associated Clinical Trials listed on BioPortfolio]

Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with c...

Nadolol Versus Propranolol in Children With Infantile Hemangiomas

The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas in a randomized, controlled, double-blinded study.

A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China

Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related ep...

Clinical Characteristics of Infantile Hemangioma

The primary purpose of this study is to identify the clinical characteristics of infantile hemangioma (IH) in our single center in China. The second objective of the study is to identify t...

Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas

Through this study, the investigators shall compare the effectiveness of atenolol with propranolol in the treatment of IH. In addition, the investigators shall try to elucidate the mechani...

PubMed Articles [1157 Associated PubMed Articles listed on BioPortfolio]

Safety Profile during Initiation of Propranolol for Treatment of Infantile Hemangiomas in an Ambulatory Day-Care Hospitalization Setting.

Propranolol is the mainstay of treatment for infantile hemangioma. Despite its good safety profile, it is not risk-free. Guidelines for propranolol initiation and monitoring have been suggested, but p...

Treatment of Facial Infantile Hemangioma: Comparative Study Between Propranolol and Ethanolamine Oleate.

Infantile hemangiomas (IH) are the most common benign vascular tumors in childhood. Approximately 10% to 15% of these tumors require drug or surgical intervention. There are many options for IH treatm...

Oral Propranolol in a Child with Infantile Hemangioma of the Urethra.

Infantile hemangiomas (IH) are the most common in the head and neck region. They can occur anywhere in the skin, however, urethral hemangiomas are very rare. We describe a case report of a three years...

Thirty-two Japanese cases of infantile hemangiomas treated with oral propranolol.

Infantile hemangiomas undergo rapid growth during early infancy followed by gradual involution. Infantile hemangiomas sometimes impair vital functions or cause disfigurement. Thirty-two Japanese patie...

Population Pharmacokinetics and Pharmacodynamics of Oral Propranolol in Pediatric Patients With Infantile Hemangioma.

This study aimed to characterize the population pharmacokinetics and exposure-response relationship of propranolol (Hemangiol Syrup for Pediatric) in infants with infantile hemangioma. Using nonlinear...

Medical and Biotech [MESH] Definitions

A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.

A benign neoplasm of pneumocytes, cells of the PULMONARY ALVEOLI. Originally considered to be vascular in origin, it is now classified as an epithelial tumor with several elements, including solid cellular areas, papillary structure, sclerotic regions, and dilated blood-filled spaces resembling HEMANGIOMA.

A dull red, firm, dome-shaped hemangioma, sharply demarcated from surrounding skin, usually located on the head and neck, which grows rapidly and generally undergoes regression and involution without scarring. It is caused by proliferation of immature capillary vessels in active stroma, and is usually present at birth or occurs within the first two or three months of life. (Dorland, 27th ed)

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Strains of ESCHERICHIA COLI characterized by attaching-and-effacing histopathology. These strains of bacteria intimately adhere to the epithelial cell membrane and show effacement of microvilli. In developed countries they are associated with INFANTILE DIARRHEA and infantile GASTROENTERITIS and, in contrast to ETEC strains, do not produce ENDOTOXINS.

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