NCT02731287

Brief Summary

Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

March 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

November 17, 2015

Last Update Submit

November 13, 2018

Conditions

Hemangioma

Outcome Measures

Primary Outcomes (1)

  • Complete or almost complete resolution of the lesions

    Efficacy to treatment at 24 weeks, categorized as complete or almost complete resolution of the lesions (almost complete resolution defined as faint macular erythema, telangiectasia and no palpable component). This will be generated by independent blind evaluations by comparing photographs at baseline and 24 weeks. The investigators will score this improvement into one of the following categories (complete resolution, improve, stabilization, worsening)

    24 weeks

Secondary Outcomes (1)

  • Adverse reactions

    24 weeks

Study Arms (2)

Timolol

EXPERIMENTAL

Timolol maleate 0.5% topical solution; 50% of the patients treated (randomized)

Drug: Timolol

Placebo

PLACEBO COMPARATOR

Saline topical solution; 50% of the patients treated (randomized)

Drug: Placebo

Interventions

TimololDRUG

The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks

Also known as: Timolol maleate 0.5%
Timolol
PlaceboDRUG

The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks

Also known as: Saline Solution
Placebo

Eligibility Criteria

Age10 Days - 60 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Written informed consent for study participation and the use of the patient's photographs from the patient's parent(s) or guardian(s),
  • The patient is between 10 and 60 days of age at the time of enrollment,
  • The patient should have:
  • at least one focal or segmental hemangioma, mixed or superficial, present anywhere on the body of at least 0.3 cm of minimum diameter and not greater of 5 cm.
  • abortive or minimal growth hemangioma
  • Infantile hemangioma precursors

You may not qualify if:

  • Patients \> 60 days of age
  • Complicated hemangiomas (life-threatening, function-threatening, or ulcerated)
  • Children who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers, PDL laser.
  • Patients with PHACES, LUMBAR, SACRAL or PELVIS syndrome.
  • Internal involvement hemangiomas (liver, GI tract, larynx)
  • Children with a personal history of asthma or cardiac conditions that may predispose to heart block.
  • Children with congenital birth defects
  • Children with Cancer (leukemia, sarcoma, neuroblastoma, retinoblastoma)
  • Children with a history of hypersensitivity to beta blockers or excipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Hemangioma

Interventions

TimololSaline Solution

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Eulalia Baselga, MD, PhD

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

April 7, 2016

Study Start

March 1, 2014

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

ES(2)