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

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ClinicalTrials.gov Identifier: NCT01512173
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermatology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Infantile Hemangioma Drug: propranolol gel Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.
Study Start Date : January 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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MedlinePlus related topics: Birthmarks

Arms and Interventions
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Arm Intervention/treatment
Experimental: propranolol gel Drug: propranolol gel
Topical administration twice daily
Placebo Comparator: Placebo Drug: Placebo
Topical administration twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Complete/nearly complete resolution of the Infantile Hemangioma at week 12. [ Time Frame: week 12 ]
    Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline


Secondary Outcome Measures :
  1. On-site parent(s) or guardian(s) qualitative assessments of efficacy [ Time Frame: week 2 , week 4, week 8, week 12 and week 24 ]
    categorical endpoints for Infantile Hemangioma evolution (4-points scale)

  2. Persistence of efficacy 12 weeks after the end of treatment [ Time Frame: Week 24 ]
    Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.

  3. Safety profile (descriptive analysis of AE) [ Time Frame: Day 0, week 2, week 4, week 8, week 12 and week 24 ]
  4. Local tolerance of the propranolol gel(description over time by treatment group) [ Time Frame: week 2, week 4, week 8 and week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   35 Days to 150 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512173


Locations
France
CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique
Bordeaux, France, 33076
Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique
Lille, France, 59020
CHU Lyon Est Hôpital mère enfant - Consultation des angiomes
Lyon Bron, France, 69677
CHU Timone - Service de dermatologie
Marseille, France, 13385
Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique
Nantes, France, 44093
CHU Necker enfants malades - Service de dermatologie
Paris, France, 75517
CHU Saint-Etienne Hôpital Nord - Service de dermatologie
Saint-Etienne, France, 42055
CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique
Toulouse, France, 31100
Hôpital de Clocheville - Centre de Pédiatrie Gatien
Tours, France, 37044
Poland
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed
Gdańsk, Poland, 80-803
Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej
Lodz, Poland, 91-738
Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii
Warszawa, Poland, 04-730
Spain
Hospital Sant Pau de Barcelona
Barcelona, Spain, 08025
Hospital Universitario Infantil Niño Jesús
Madrid, Spain, 28009
Hospital La Paz
Madrid, Spain, 28056
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Sponsors and Collaborators
Pierre Fabre Dermatology
More Information
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Responsible Party: Pierre Fabre Dermatology
ClinicalTrials.gov Identifier: NCT01512173     History of Changes
Other Study ID Numbers: V00400 GL 2 01 1A
2011-003144-50 ( EudraCT Number )
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014

Keywords provided by Pierre Fabre Dermatology:
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

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Propranolol
 Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents