Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

Hemangioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731287
• Other study ID #: IIBSP-TIM-2013-156
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: November 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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.

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Port-Wine Stain

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Virgen del Rocío	Sevilla

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 weeks