NCT02342275

Brief Summary

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
377

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

June 16, 2022

Completed
Last Updated

June 16, 2022

Status Verified

March 1, 2022

Enrollment Period

4.9 years

First QC Date

January 7, 2015

Results QC Date

October 31, 2021

Last Update Submit

March 12, 2022

Conditions

Hemangioma

Keywords

Infantile hemangiomaPropranololAtenololEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Measure Was Any Response at 6 Months

    Changes in IH size and color were classified as a complete response, nearly complete response, partial response or no response. The primary outcome measure was any response at 6 months in the intention-to-treat population of all patients who underwent randomization. The any response included compete, nearly complete and partial responses. A complete response was defined as no redundant tissue or telangiectasia was identified. A nearly complete response was defined as a minimal degree of telangiectasis, erythema and skin thickening. A partial response was defined as a size reduction or change in color that did not meet the nearly complete resolution criteria.

    6 month

Secondary Outcomes (5)

  • Hemangioma Activity Score (HAS)

    Baseline and at 1, 4, 12, and 24 weeks

  • Successful Initial Response

    1 week after treatment

  • Complete Ulceration Healing Time

    from the first dosage of propranolol or atenolol until complete healing ofthe hemangioma ulceration.

  • Rebound Rate

    between weeks 24 and 96

  • Number of Participants With Complete/Nearly Complete Response (96 Week)

    96 week

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

Propranolol

Drug: Propranolol

Atenolol

ACTIVE COMPARATOR

Atenolol

Drug: Atenolol

Interventions

PropranololDRUG

Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.

Also known as: Oral propranolol
Propranolol
AtenololDRUG

Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.

Also known as: Oral atenolol
Atenolol

Eligibility Criteria

AgeUp to 24 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients younger than 24 weeks.
  • Presenting a hemangioma with the following characteristics:
  • Subcutaneous and/or cutaneous
  • Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
  • Consent of both parents (or the person having parental authority in families)

You may not qualify if:

  • Infant presenting contraindications for the administration of propranolol or atenolol.
  • Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
  • Patients with an inability to participate or to follow the study treatment and assessment plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (7)

  • Ji Y, Chen S, Xu C, Li L, Xiang B. The use of propranolol in the treatment of infantile haemangiomas: an update on potential mechanisms of action. Br J Dermatol. 2015 Jan;172(1):24-32. doi: 10.1111/bjd.13388. Epub 2014 Dec 17.

    PMID: 25196392BACKGROUND

  • Ji Y, Chen S, Li K, Li L, Xu C, Xiang B. Signaling pathways in the development of infantile hemangioma. J Hematol Oncol. 2014 Jan 31;7:13. doi: 10.1186/1756-8722-7-13.

    PMID: 24479731BACKGROUND

  • Ji Y, Chen S, Li K, Xiao X, Zheng S. Propranolol: a novel antihemangioma agent with multiple potential mechanisms of action. Ann Surg. 2015 Feb;261(2):e52-3. doi: 10.1097/SLA.0000000000000450. No abstract available.

    PMID: 24374526BACKGROUND

  • Ji Y, Chen S, Li K, Xiao X, Xu T, Zheng S. Upregulated autocrine vascular endothelial growth factor (VEGF)/VEGF receptor-2 loop prevents apoptosis in haemangioma-derived endothelial cells. Br J Dermatol. 2014 Jan;170(1):78-86. doi: 10.1111/bjd.12592.

    PMID: 24033364BACKGROUND

  • de Graaf M, Raphael MF, Breugem CC, Knol MJ, Bruijnzeel-Koomen CA, Kon M, Breur JM, Pasmans SG. Treatment of infantile haemangiomas with atenolol: comparison with a historical propranolol group. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1732-40. doi: 10.1016/j.bjps.2013.07.035. Epub 2013 Sep 4.

    PMID: 24011909BACKGROUND

  • Raphael MF, de Graaf M, Breugem CC, Pasmans SGMA, Breur JMPJ. Atenolol: a promising alternative to propranolol for the treatment of hemangiomas. J Am Acad Dermatol. 2011 Aug;65(2):420-421. doi: 10.1016/j.jaad.2010.11.056. No abstract available.

    PMID: 21763565BACKGROUND

  • Ji Y, Chen S, Yang K, Zhang X, Zhou J, Li L, Xiang B, Qiu T, Dai S, Jiang X, Lu G, Qiu L, Kong F, Zhang Y. Efficacy and Safety of Propranolol vs Atenolol in Infants With Problematic Infantile Hemangiomas: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):599-607. doi: 10.1001/jamaoto.2021.0454.

    PMID: 33856430DERIVED

MeSH Terms

Conditions

HemangiomaHemangioma, Capillary

Interventions

PropranololAtenolol

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Yi jJi
Organization
Sichuan University
jijiyuanyuan@163.com
+86 02885423453

Study Officials

  • Yi Ji, MD, PhD

    West China Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 19, 2015

Study Start

October 1, 2013

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

June 16, 2022

Results First Posted

June 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)