Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
- Registration Number
- NCT01512173
- Lead Sponsor
- Pierre Fabre Dermatology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description propranolol gel propranolol gel - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Complete/nearly complete resolution of the Infantile Hemangioma at week 12. week 12 Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline
- Secondary Outcome Measures
Name Time Method Persistence of efficacy 12 weeks after the end of treatment Week 24 Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.
Local tolerance of the propranolol gel(description over time by treatment group) week 2, week 4, week 8 and week 12 On-site parent(s) or guardian(s) qualitative assessments of efficacy week 2 , week 4, week 8, week 12 and week 24 categorical endpoints for Infantile Hemangioma evolution (4-points scale)
Safety profile (descriptive analysis of AE) Day 0, week 2, week 4, week 8, week 12 and week 24
Trial Locations
- Locations (17)
Hospital La Paz
🇪🇸Madrid, Spain
CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique
🇫🇷Bordeaux, France
Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique
🇫🇷Lille, France
CHU Timone - Service de dermatologie
🇫🇷Marseille, France
CHU Lyon Est Hôpital mère enfant - Consultation des angiomes
🇫🇷Lyon Bron, France
Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique
🇫🇷Nantes, France
CHU Saint-Etienne Hôpital Nord - Service de dermatologie
🇫🇷Saint-Etienne, France
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed
🇵🇱Gdańsk, Poland
Hôpital de Clocheville - Centre de Pédiatrie Gatien
🇫🇷Tours, France
Hospital Sant Pau de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Infantil Niño Jesús
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
CHU Necker enfants malades - Service de dermatologie
🇫🇷Paris, France
CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique
🇫🇷Toulouse, France
Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii
🇵🇱Warszawa, Poland
Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej
🇵🇱Lodz, Poland