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NCT Number: NCT02731287

Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

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.

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Key information

Conditions

Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

10 day–60 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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About this study

A multicentric, randomized, double-blind, placebo-controlled, phase II clinical trial to evaluate the efficacy and safety of 0.5% timolol maleate solution for the early treatment of infantile hemangioma.

Patients with less of 60 days of life with focal or segmental hemangiomas, superficial, mixed or abortive will be treated with topical timolol 0.5% twice a day for 24 weeks.

Changes in lesion size, color and thickness will be evaluated from photographs taken at 2,4,8,12,24 and 36 weeks. Vital signs and side effects will be recorded at each visit. Response to treatment will be evaluated by a blinded investigator in a semiquantitative scale (complete resolution, improve, stabilization, worsening).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Timolol

Drug

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

Other names: Timolol maleate 0.5%

Placebo

Drug

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

Other names: Saline Solution

Primary outcomes

  1. Complete or almost complete resolution of the lesions

    Time frame: 24 weeks

    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)

Secondary outcomes

  1. Adverse reactions

    Time frame: 24 weeks

    Evaluation of safety and adverse reactions. The investigators will monitor vital signs of the patients every follow-up visit and ask the caretakers about side effects and adverse reactions to treatment.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Efficacy and Safety of Topical Timolol Maleate 0.5% Solution for Superficial Infantile Hemangioma in Early Proliferative Phase. A Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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