Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

propranolol gel

Placebo

There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.

Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.

The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.

Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo

A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.

Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline

categorical endpoints for Infantile Hemangioma evolution (4-points scale)

Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.

Pierre Fabre Dermatology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo	NCT01512173	Infantile Heman...	propranolol gel Placebo	35 Days - 150 Days	Pierre Fabre Dermatology
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo	NCT01512173	Infantile Heman...	propranolol gel Placebo	35 Days - 150 Days	Pierre Fabre Dermatology

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