Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
This study has been completed.
Sponsor:
Pierre Fabre Dermatology
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
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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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01512173
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 February 25, 2015