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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Topical administration twice daily
Topical administration twice daily
CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique
Bordeaux, France
Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique
Lille, France
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
Time frame: week 12
On-site parent(s) or guardian(s) qualitative assessments of efficacy
categorical endpoints for Infantile Hemangioma evolution (4-points scale)
Time frame: week 2 , week 4, week 8, week 12 and week 24
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.
Time frame: Week 24
Safety profile (descriptive analysis of AE)
Time frame: Day 0, week 2, week 4, week 8, week 12 and week 24
Local tolerance of the propranolol gel(description over time by treatment group)
Time frame: week 2, week 4, week 8 and week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed
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...and 7 more locations