Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma

NCT07665177 | Not Yet Recruiting Phase 4

• 1 other identifier: RCT20260618
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infantile Hemangioma (IH)

Keywords

Infantile hemangioma; Propranolol; rebound growth

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 months after complete discontinuation of propranolol

Secondary Outcomes (4)

• Time to Rebound Growth

  Up to 3 months after complete discontinuation of propranolol

• Age at Rebound Growth

  Up to 3 months after complete discontinuation of propranolol

• Post-Rebound Treatment

  Up to 3 months after complete discontinuation of propranolol

• Incidence of Clinically Significant Rebound Growth

  Up to 3 months after complete discontinuation of propranolol

Study Arms (2)

Abrupt Discontinuation Group

EXPERIMENTAL

Participants assigned to this group will discontinue propranolol abruptly after meeting predefined discontinuation criteria for infantile hemangioma.

Drug: Abrupt Discontinuation of Propranolol

Gradual Tapering Group

ACTIVE COMPARATOR

Participants assigned to this group will undergo gradual tapering of propranolol before complete discontinuation after meeting predefined discontinuation criteria for infantile hemangioma.

Drug: Gradual Tapering of Propranolol

Interventions

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.

Abrupt Discontinuation Group

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.

Gradual Tapering Group

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Written informed consent is provided by a parent or legal guardian.
• The parent or legal guardian is able and willing to complete the scheduled follow-up assessments.

You may not qualify if:

• 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.
• Severe cardiac, respiratory, hepatic, renal, metabolic, or other systemic disease that may affect participant safety or study assessment.
• Inability to complete standardized photography, ultrasound assessment, or scheduled follow-up.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yi Ji, MD, PhD

CONTACT

862885423453; jijiyuanyuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the discontinuation strategies, participants, care providers, and investigators will not be masked to group assignment. Rebound growth will be assessed using standardized photographs and/or ultrasound by outcome assessors who are masked to the assigned discontinuation strategy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)