Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma

ConditionInfantile Hemangioma (IH)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age6-60

SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children with a clinical diagnosis of infantile hemangioma.

Complete pretreatment clinical documentation is available, including clinical photographs and/or ultrasound findings.

The child has received oral propranolol for at least 6 months.

The infantile hemangioma meets the predefined criteria for propranolol discontinuation, defined as complete or near-complete clinical regression, no obvious residual blood flow on ultrasound, and stable maximal regression for 3 months.

Disqualifiers

Airway or hepatic infantile hemangiomas, or other high-risk lesions for which rebound growth could rapidly compromise life or vital organ function.

Use of propranolol for arrhythmia, hypertension, or another cardiovascular indication.

A history of rebound growth after prior discontinuation of propranolol.

Laser therapy, sclerotherapy, surgery, systemic corticosteroids, or other systemic treatment within 3 months before randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

Abrupt Discontinuation of Propranolol
Drug
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
Drug
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.

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: Abrupt Discontinuation GroupExperimental treatment 1 intervention

Group B: Gradual Tapering GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of Rebound Growth Following Propranolol Discontinuation

Rebound growth is defined as a greater than 20% increase in the visible extent of the infantile hemangioma after propranolol has been stopped, including change in color and/or volume. Rebound growth will be assessed by blinded outcome assessors using standardized clinical photographs and/or ultrasound.

Time frame