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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.

Conditions
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Infantile Hemangioma

Intervention / Treatment
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* Drug: propranolol gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Days
Maximum Age: 150 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propranolol gel<br> | Drug: propranolol gel<br>* Topical administration twice daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Topical administration twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-site parent(s) or guardian(s) qualitative assessments of efficacy | categorical endpoints for Infantile Hemangioma evolution (4-points scale) | week 2 , week 4, week 8, week 12 and week 24 | 
| Persistence of efficacy 12 weeks after the end of treatment | Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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