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

Information source: Pierre Fabre Dermatology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infantile Hemangioma

Intervention: propranolol gel (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pierre Fabre Dermatology

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 Details

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

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

Primary outcome: Complete/nearly complete resolution of the Infantile Hemangioma at week 12.

Secondary outcome:

On-site parent(s) or guardian(s) qualitative assessments of efficacy

Persistence of efficacy 12 weeks after the end of treatment

Safety profile (descriptive analysis of AE)

Local tolerance of the propranolol gel(description over time by treatment group)

Eligibility

Minimum age: 35 Days. Maximum age: 150 Days. Gender(s): Both.

Criteria:

Main Inclusion Criteria:

- only one proliferating Infantile Hemangioma present anywhere on the body except on

the head, the neck, the hands and on the diaper area, with largest diameter diameter ≥ 1cm and ≤ 5 cm. Main Exclusion Criteria:

- more than one Infantile Hemangioma with largest diameter ≥ 1cm

- medically unstable health status that may interfere with his/her ability to complete

the study

- Infantile Hemangioma requires, according to Investigator's judgment, a systemic

treatment

- the patient has previously been administered treatment for IH or surgical and/or

medical procedures (e. g. laser therapy) have been performed to treat the IH

Locations and Contacts

CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique, Bordeaux 33076, France

Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique, Lille 59020, France

CHU Lyon Est Hôpital mère enfant - Consultation des angiomes, Lyon Bron 69677, France

CHU Timone - Service de dermatologie, Marseille 13385, France

Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique, Nantes 44093, France

CHU Necker enfants malades - Service de dermatologie, Paris 75517, France

CHU Saint-Etienne Hôpital Nord - Service de dermatologie, Saint-Etienne 42055, France

CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique, Toulouse 31100, France

Hôpital de Clocheville - Centre de Pédiatrie Gatien, Tours 37044, France

Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed, Gdańsk 80-803, Poland

Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej, Lodz 91-738, Poland

Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii, Warszawa 04-730, Poland

Hospital Sant Pau de Barcelona, Barcelona 08025, Spain

Hospital La Paz, Madrid 28056, Spain

Hospital Universitario Infantil Niño Jesús, Madrid 28009, Spain

Hospital Universitario Virgen del Rocio, Sevilla 41013, Spain

Hospital General Universitario de Valencia, Valencia 46014, Spain

Additional Information

Starting date: January 2012
Last updated: October 29, 2014

Page last updated: August 23, 2015

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