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 Details — Status: Completed

Administrative data

• NCT number: NCT01512173
• Other study ID #: V00400 GL 2 01 1A
• Secondary ID: 2011-003144-50
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2012
• Last updated: October 29, 2014
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Pierre Fabre Dermatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Agencia Española de Medicamentos y Productos SanitariosPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Days to 150 Days

Eligibility

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

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

• Hemangioma
• Hemangioma, Capillary
• Infantile Hemangioma
• Port-Wine Stain

Intervention

Drug:
• propranolol gel
Topical administration twice daily
• Placebo
Topical administration twice daily

Locations

Country	Name	City	State
France	CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique	Bordeaux
France	Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique	Lille
France	CHU Lyon Est Hôpital mère enfant - Consultation des angiomes	Lyon Bron
France	CHU Timone - Service de dermatologie	Marseille
France	Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique	Nantes
France	CHU Necker enfants malades - Service de dermatologie	Paris
France	CHU Saint-Etienne Hôpital Nord - Service de dermatologie	Saint-Etienne
France	CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique	Toulouse
France	Hôpital de Clocheville - Centre de Pédiatrie Gatien	Tours
Poland	Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku Klinika Chirurgii i Urologii Dzieci i Mlodziezy GUMed	Gdansk
Poland	Uniwersytet Medyczny w Lodzi Klinika Chirurgii i Onkologii Dzieciecej	Lodz
Poland	Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii	Warszawa
Spain	Hospital Sant Pau de Barcelona	Barcelona
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Infantil Niño Jesús	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermatology

Countries where clinical trial is conducted

France,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete/nearly complete resolution of the Infantile Hemangioma at week 12.	Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline	week 12	No
Secondary	On-site parent(s) or guardian(s) qualitative assessments of efficacy	categorical endpoints for Infantile Hemangioma evolution (4-points scale)	week 2 , week 4, week 8, week 12 and week 24	No
Secondary	Persistence of efficacy 12 weeks after the end of treatment	Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.	Week 24	No
Secondary	Safety profile (descriptive analysis of AE)		Day 0, week 2, week 4, week 8, week 12 and week 24	Yes
Secondary	Local tolerance of the propranolol gel(description over time by treatment group)		week 2, week 4, week 8 and week 12	Yes