Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

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

Status and phase

Completed

Phase 2

Conditions

Hemangioma

Treatments

Drug: Placebo

Drug: Timolol

Study type

Interventional

Funder types

Other

Identifiers

NCT02731287

IIBSP-TIM-2013-156

Details and patient eligibility

About

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.

Full 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).

Enrollment

70 patients

Sex

All

Ages

10 to 60 days old

Volunteers

No 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.