Status:
COMPLETED
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
Lead Sponsor:
Pierre Fabre Dermatology
Conditions:
Infantile Hemangioma
Eligibility:
All Genders
35-150 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01512173
Start Date
January 1 2012
End Date
May 1 2013
Last Update
October 30 2014
Active Locations (17)
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1
CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique
Bordeaux, France, 33076
2
Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique
Lille, France, 59020
3
CHU Lyon Est Hôpital mère enfant - Consultation des angiomes
Lyon Bron, France, 69677
4
CHU Timone - Service de dermatologie
Marseille, France, 13385