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Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

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ClinicalTrials.gov Identifier: NCT02731287
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease Intervention/treatment Phase
Hemangioma Drug: Timolol Drug: Placebo Phase 2

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Timolol Maleate 0.5% Solution for Superficial Infantile Hemangioma in Early Proliferative Phase. A Randomized Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
Experimental: Timolol
Timolol maleate 0.5% topical solution; 50% of the patients treated (randomized)
Drug: Timolol
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 Name: Timolol maleate 0.5%

Placebo Comparator: Placebo
Saline topical solution; 50% of the patients treated (randomized)
Drug: Placebo
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 Name: Saline Solution




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731287


Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Eulalia Baselga, MD, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02731287     History of Changes
Other Study ID Numbers: IIBSP-TIM-2013-156
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Pharmaceutical Solutions
Timolol
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors