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Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma
Sponsor: West China Hospital
Summary
Infantile hemangioma is the most common benign vascular tumor in infancy. Oral propranolol is the first-line systemic treatment for infantile hemangiomas requiring therapy. Although most patients respond well to propranolol, rebound growth may occur after treatment discontinuation, and some patients may require restarting propranolol or receiving additional treatment. In clinical practice, propranolol may be discontinued abruptly after the lesion meets discontinuation criteria, or gradually tapered over several weeks before complete discontinuation. However, high-quality randomized evidence comparing these two discontinuation strategies remains limited. This multicenter randomized noninferiority trial aims to compare the risk of rebound growth after abrupt discontinuation versus gradual tapering of propranolol in patients with infantile hemangioma who have received oral propranolol for at least 6 months and meet predefined discontinuation criteria.
Official title: Rebound Growth After Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma: A Multicenter Randomized Noninferiority Trial
Key Details
Gender
All
Age Range
6 Months - 60 Months
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2026-07-01
Completion Date
2028-03-30
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
Abrupt Discontinuation of Propranolol
Propranolol will be stopped immediately once the participant meets predefined discontinuation criteria, including complete or near-complete clinical regression, no obvious blood flow on ultrasound, and maintenance of maximal regression for 3 months.
Gradual Tapering of Propranolol
The propranolol dose will be reduced to half of the original total daily dose for the first 2 weeks, then reduced to one quarter of the original total daily dose for another 2 weeks, and propranolol will be discontinued in week 5.
Locations (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, China