Timolol Maleate Gel for the Treatment of Infantile Hemangioma

Inclusion criteria

• Male or female infants at the age of 35 ~ 150 days;
• Infant subjects with definitive diagnosis of superficial hemangioma requiring treatment based on medical history, clinical manifestations, and imaging examination (B-ultrasonography, CT or MRI) results;
• Infant subjects with single hemangioma lesion;
• Infant subjects with the maximum hemangioma diameter being ≥ 1 cm but ≤ 10 cm;
• Infant subject with CEA ≥ Grade 2; The guardians of the infant subject understood the study contents and risks of study treatment, signed the informed consent form (ICF), and were willing to cooperate with the study conduct.

Exclusion criteria

• Infant subjects who were known to be allergic to or had history of severe allergy to timolol maleate or other β-receptor blockers;
• Infant subjects who had previously been treated with systemic, intralesional or topical corticosteroids, vincristine, α-interferon, imiquimod, propranolol, or other β-receptor blockers;
• Infant subjects breastfed by mother who was treated with β-receptor blockers, systemic (oral, intravenous or intramuscular) corticosteroids, vincristine or α-interferon while breastfeeding;
• Infant subjects who born more than 2 months premature and younger than 60 days old;
• Infant subjects who had previously been treated for hemangioma (including surgery, hormonal drugs, laser therapy, etc.);
• Infant subjects with more than one type of hemangioma requiring treatment;
• Infant subjects with other skin diseases on the hemangioma surface and surrounding skin areas, such as eczema, infantile eczema, etc.
• Infant subjects who had atrioventricular block ≥ second-degree, bradycardia (heart rate < 100 bpm), sinoatrial syndrome, cardiogenic shock, or other congenital cardiac disorders;
• Infant subjects who were suffering from respiratory disorders such as bronchial asthma, bronchospasm and pneumonia;
• Infant subjects who were suffering from central nervous system disorders, or had symptoms of increased intracranial pressure, or had other underlying diseases that might cause or aggravate infantile hemangioma;
• Infant subjects who had systolic blood pressure < 50 mmHg or diastolic blood pressure < 30 mmHg;
• Infant subjects who received any other investigational drug within 4 weeks prior to screening; Infant subjects with other conditions not suitable for enrollment at the discretion of the investigator.