Infantile Hemangioma
Conditions
Keywords
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
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.
Interventions
DRUGpropranolol gel
Topical administration twice daily
DRUGPlacebo
Topical administration twice daily
Sponsors
Pierre Fabre Dermatology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Days to 150 Days
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete/nearly complete resolution of the Infantile Hemangioma at week 12. | week 12 | Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| On-site parent(s) or guardian(s) qualitative assessments of efficacy | week 2 , week 4, week 8, week 12 and week 24 | categorical endpoints for Infantile Hemangioma evolution (4-points scale) |
| Persistence of efficacy 12 weeks after the end of treatment | Week 24 | Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12. |
| 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 | — |
Countries
France, Poland, Spain
Outcome results
None listed