Complete or Nearly Complete Resolution After 6 Months of Therapy
Statistically significant response was shown in patients treated with HEMANGEOL versus placebo
In a pivotal Phase II/III clinical trial (n=460), 4 regimens were compared: 1.2 or 3.4 mg/ kg/day in twice daily divided doses for 3 or for 6 months as compared to placebo.
- 60% of infants receiving HEMANGEOL vs. 4% of those in the placebo group
met the primary endpoint of complete or nearly complete resolution of infantile hemangioma (P<0.0001)
- 88% of patients on HEMANGEOL showed improvement of infantile hemangioma after 5 weeks of treatment1
- 10% of successful patients at week 24 required retreatment of their infantile hemangioma
- Life-threatening infantile hemangioma, function-threatening infantile hemangioma, and ulcerated infantile hemangioma with pain and lack of response to simple wound care measures were excluded
- 10% of infants required retreatment of their infantile hemangioma
In a second open-label study, target lesions resolved by 3 months in 36% of infants with proliferating infantile hemangioma, including:
- Function-threatening infantile hemangioma
- Infantile hemangioma in certain anatomic locations that often leave scars or deformity
- Large facial infantile hemangioma
- Smaller infantile hemangioma in exposed areas
- Severe ulcerated infantile hemangioma
- Pedunculated infantile hemangioma
Efficacy At a Glance
Before and After HEMANGEOL Treatment*
*individual results may vary
Before and After Treatment With Placebo
*The international, double-blind, placebo-controlled, phase II/III trial enrolled 460 infants 5 weeks to 5 months of age with proliferative phase infantile hemangioma.
The study compared 4 regimens of HEMANGEOL (1.2 mg/kg/day or 3.4 mg/kg/day for 3 to 6 months) against placebo. Life-threatening infantile hemangioma, function-threatening infantile hemangioma, and ulcerated infantile hemangioma with pain and lack of response to simple wound care measures were excluded.