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

Infantile Hemangioma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01512173
Study type Interventional
Source Pierre Fabre Dermatology
Contact
Status Completed
Phase Phase 2
Start date January 2012
Completion date May 2013
View Details
See also
  Status Clinical Trial Phase
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Recruiting NCT04288700 - Evaluation of the Efficacy of Captopril Versus Propranolol and Timolol as a Treatment of Infantile Capillary Hemangioma Phase 4
Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT01010308 - Nadolol for Proliferating Infantile Hemangiomas Phase 2
Completed NCT02913612 - Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH) Phase 2
Completed NCT01673971 - Optical Tomographic Imaging of Infantile Hemangiomas
Recruiting NCT03237637 - Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas Phase 3
Recruiting NCT05479123 - Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas Phase 4
Terminated NCT01434849 - Timolol for the Prevention of Proliferation of Infantile Hemangioma (TiPPIH Trial) Phase 1
Completed NCT04105517 - Hemangiol, Post Marketing Surveillance Study
Completed NCT01056341 - Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy Phase 2/Phase 3
Not yet recruiting NCT04684667 - ''Efficacy of Propranolol in the Treatment of Infantile Hemangioma" Phase 2
Recruiting NCT03842631 - Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination
Recruiting NCT03173352 - A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China N/A