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Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

Primary Purpose

Hemangioma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Timolol
Placebo
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma

Eligibility Criteria

10 Days - 60 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau
  • Hospital Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Timolol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Adverse reactions
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.

Full Information

First Posted
November 17, 2015
Last Updated
November 13, 2018
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT02731287
Brief Title
Topical Timolol for Infantile Hemangioma in Early Proliferative Phase
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Timolol
Arm Type
Experimental
Arm Description
Timolol maleate 0.5% topical solution; 50% of the patients treated (randomized)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline topical solution; 50% of the patients treated (randomized)
Intervention Type
Drug
Intervention Name(s)
Timolol
Other Intervention Name(s)
Timolol maleate 0.5%
Intervention Description
The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline Solution
Intervention Description
The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
Primary Outcome Measure Information:
Title
Complete or almost complete resolution of the lesions
Description
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)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Days
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eulalia Baselga, MD, PhD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

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Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

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