NCT01512173

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

January 6, 2012

Last Update Submit

October 29, 2014

Conditions

Infantile Hemangioma

Keywords

Propranolol gelHemangiomacapillary neoplasmvascular tissueneoplasm by histologic typeneoplasmtherapeutic usespharmacologic actionsadrenergic beta-antagonistsadrenergic antagonistadrenergics agentneurotransmitter agentmolecular mechanism of pharmacological actionphysiological effects of drugs

Outcome Measures

Primary Outcomes (1)

  • 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

    week 12

Secondary Outcomes (4)

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

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

  • Persistence of efficacy 12 weeks after the end of treatment

    Week 24

  • Safety profile (descriptive analysis of AE)

    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)

    week 2, week 4, week 8 and week 12

Study Arms (2)

propranolol gel

EXPERIMENTAL
Drug: propranolol gel

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

propranolol gelDRUG

Topical administration twice daily

propranolol gel
PlaceboDRUG

Topical administration twice daily

Placebo

Eligibility Criteria

Age35 Days - 150 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique

Bordeaux, 33076, France

Location

Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique

Lille, 59020, France

Location

CHU Lyon Est Hôpital mère enfant - Consultation des angiomes

Lyon Bron, 69677, France

Location

CHU Timone - Service de dermatologie

Marseille, 13385, France

Location

Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique

Nantes, 44093, France

Location

CHU Necker enfants malades - Service de dermatologie

Paris, 75517, France

Location

CHU Saint-Etienne Hôpital Nord - Service de dermatologie

Saint-Etienne, 42055, France

Location

CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique

Toulouse, 31100, France

Location

Hôpital de Clocheville - Centre de Pédiatrie Gatien

Tours, 37044, France

Location

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

Gdansk, 80-803, Poland

Location

Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej

Lodz, 91-738, Poland

Location

Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii

Warsaw, 04-730, Poland

Location

Hospital Sant Pau de Barcelona

Barcelona, 08025, Spain

Location

Hospital Universitario Infantil Niño Jesús

Madrid, 28009, Spain

Location

Hospital La Paz

Madrid, 28056, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Hemangioma, CapillaryHemangiomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 19, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

ES(5)PL(3)FR(9)