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

Primary Purpose

Infantile Hemangioma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

propranolol gel

Placebo

About this trial

This is an interventional treatment trial for Infantile Hemangioma focused on measuring 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

Eligibility Criteria

35 Days - 150 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique
Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique
CHU Lyon Est Hôpital mère enfant - Consultation des angiomes
CHU Timone - Service de dermatologie
Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique
CHU Necker enfants malades - Service de dermatologie
CHU Saint-Etienne Hôpital Nord - Service de dermatologie
CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique
Hôpital de Clocheville - Centre de Pédiatrie Gatien
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed
Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej
Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii
Hospital Sant Pau de Barcelona
Hospital Universitario Infantil Niño Jesús
Hospital La Paz
Hospital Universitario Virgen del Rocio
Hospital General Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

propranolol gel

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

On-site parent(s) or guardian(s) qualitative assessments of efficacy

categorical endpoints for Infantile Hemangioma evolution (4-points scale)

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.

Safety profile (descriptive analysis of AE)

Local tolerance of the propranolol gel(description over time by treatment group)

Full Information

NCT ID

NCT01512173

First Posted

January 6, 2012

Last Updated

October 29, 2014

Sponsor

Pierre Fabre Dermatology

1. Study Identification

Unique Protocol Identification Number

NCT01512173

Brief Title

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

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Dermatology

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

propranolol gel

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

propranolol gel

Intervention Description

Topical administration twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Topical administration twice daily

Primary Outcome Measure Information:

Title

Complete/nearly complete resolution of the Infantile Hemangioma at week 12.

Description

Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline

Time Frame

week 12

Secondary Outcome Measure Information:

Title

On-site parent(s) or guardian(s) qualitative assessments of efficacy

Description

categorical endpoints for Infantile Hemangioma evolution (4-points scale)

Time Frame

week 2 , week 4, week 8, week 12 and week 24

Title

Persistence of efficacy 12 weeks after the end of treatment

Description

Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.

Time Frame

Week 24

Title

Safety profile (descriptive analysis of AE)

Time Frame

Day 0, week 2, week 4, week 8, week 12 and week 24

Title

Local tolerance of the propranolol gel(description over time by treatment group)

Time Frame

week 2, week 4, week 8 and week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Days

Maximum Age & Unit of Time

150 Days

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

CHU Lyon Est Hôpital mère enfant - Consultation des angiomes

City

Lyon Bron

ZIP/Postal Code

69677

Country

France

Facility Name

CHU Timone - Service de dermatologie

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

CHU Necker enfants malades - Service de dermatologie

City

Paris

ZIP/Postal Code

75517

Country

France

Facility Name

CHU Saint-Etienne Hôpital Nord - Service de dermatologie

City

Saint-Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique

City

Toulouse

ZIP/Postal Code

31100

Country

France

Facility Name

Hôpital de Clocheville - Centre de Pédiatrie Gatien

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed

City

Gdańsk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej

City

Lodz

ZIP/Postal Code

91-738

Country

Poland

Facility Name

Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Hospital Sant Pau de Barcelona

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital Universitario Infantil Niño Jesús

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital La Paz

City

Madrid

ZIP/Postal Code

28056

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital General Universitario de Valencia

City

Valencia

ZIP/Postal Code

46014

Country

Spain

12. IPD Sharing Statement

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

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