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 (Child) |
| 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.
For general information, see Learn About Clinical Studies.
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 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
| 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 Port-Wine Stain Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Skin Abnormalities Congenital Abnormalities Skin Diseases Propranolol |
Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on September 27, 2016