NCT01512173

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Pierre Fabre Dermatology · Industry
• Sex: All
• Age: 35 Days – 150 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infantile Hemangioma

Interventions

Type	Name	Description
DRUG	propranolol gel	Topical administration twice daily
DRUG	Placebo	Topical administration twice daily

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-01-19
• Last updated: 2014-10-30

Locations

17 sites across 3 countries: France, Poland, Spain