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

Phase 2

Completed

• Conditions: Infantile Hemangioma
• Interventions: Drug: propranolol gel; Drug: 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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-19
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

• 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)

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, France

Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed; 🇵🇱 Gdańsk, Poland

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