Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermatology
ClinicalTrials.gov Identifier:
NCT01512173
First received: January 6, 2012
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Infantile Hemangioma
Drug: propranolol gel
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Dermatology:

Primary Outcome Measures:
  • Complete/nearly complete resolution of the Infantile Hemangioma at week 12. [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 2 , week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: No ]
    categorical endpoints for Infantile Hemangioma evolution (4-points scale)

  • Persistence of efficacy 12 weeks after the end of treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.

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

Enrollment: 82
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: propranolol gel Drug: propranolol gel
Topical administration twice daily
Placebo Comparator: Placebo Drug: Placebo
Topical administration twice daily

  Eligibility

Ages Eligible for Study:   35 Days to 150 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 La Paz
Madrid, Spain, 28056
Hospital Universitario Infantil Niño Jesús
Madrid, Spain, 28009
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Sponsors and Collaborators
Pierre Fabre Dermatology
  More Information

No publications provided

Responsible Party: Pierre Fabre Dermatology
ClinicalTrials.gov Identifier: NCT01512173     History of Changes
Other Study ID Numbers: V00400 GL 2 01 1A, 2011-003144-50
Study First Received: January 6, 2012
Last Updated: October 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Molecular Mechanisms of Pharmacological Action
Propranolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014