Clinical trial NCT01512173: Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
Official title: A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infantile Hemangioma
Keywords: Propranolol gel
Hemangioma
capillary neoplasm
vascular tissue
neoplasm by histologic type
neoplasm
therapeutic uses
pharmacologic actions
adrenergic beta-antagonists
adrenergic antagonist
adrenergics agent
neurotransmitter agent
molecular mechanism of pharmacological action
physiological effects of drugs
Lead sponsor: Pierre Fabre Dermatology
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 82
Sex: ALL
Minimum age (years): 35
Maximum age (years): 150
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Complete/nearly complete resolution of the Infantile Hemangioma at week 12.
timeFrame: week 12
Secondary outcomes:
measure: On-site parent(s) or guardian(s) qualitative assessments of efficacy
timeFrame: week 2 , week 4, week 8, week 12 and week 24
measure: Persistence of efficacy 12 weeks after the end of treatment
timeFrame: Week 24
measure: Safety profile (descriptive analysis of AE)
timeFrame: Day 0, week 2, week 4, week 8, week 12 and week 24
measure: Local tolerance of the propranolol gel(description over time by treatment group)
timeFrame: week 2, week 4, week 8 and week 12
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique
city: Lyon Bron
country: France
facility: CHU Lyon Est Hôpital mère enfant - Consultation des angiomes
city: Marseille
country: France
facility: CHU Timone - Service de dermatologie
city: Nantes
country: France
facility: Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique
city: Paris
country: France
facility: CHU Necker enfants malades - Service de dermatologie
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne Hôpital Nord - Service de dermatologie
city: Toulouse
country: France
facility: CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique
city: Tours
country: France
facility: Hôpital de Clocheville - Centre de Pédiatrie Gatien
city: Gdańsk
country: Poland
facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed
city: Lodz
country: Poland
facility: Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej
city: Warszawa
country: Poland
facility: Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii
city: Barcelona
country: Spain
facility: Hospital Sant Pau de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Infantil Niño Jesús
city: Madrid
country: Spain
facility: Hospital La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
References: